Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT01641809
Collaborator
GlaxoSmithKline (Industry)
244
48
4
77.3
5.1
0.1
Study Details
Study Description
Brief Summary
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects.
This study consists of two parts:
Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4 treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete 24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1 ribonucleic acid [RNA] <50 copies per milliliter [c/mL] before Week 24, with no signs of virologic rebound) will become eligible for the Maintenance Phase of this study.
Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects randomized to the EFV arm will continue on their randomized regimen through Week 96.
After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and until it is locally approved and commercially available.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIb, Dose Ranging Study of Oral GSK1265744 in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppression When Oral GSK1265744 is Combined With Oral Rilpivirine in HIV-1 Infected, Antiretroviral Therapy Naive Adult Subjects
Actual Study Start Date
:
Aug 6, 2012
Actual Primary Completion Date
:
Oct 10, 2013
Actual Study Completion Date
:
Jan 15, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 GSK1265744 10 mg In the Induction Phase subjects will receive oral tablets of GSK1265744 10 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 10 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96. |
Drug: GSK1265744 10 mg
GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Drug: Rilpivirine 25 mg
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Drug: Placebo
Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
|
| Experimental: Arm 2 GSK1265744 30 mg In the Induction Phase subjects will receive oral tablets of GSK1265744 30 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 30 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96. |
Drug: GSK1265744 30 mg
GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Drug: Rilpivirine 25 mg
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Drug: Placebo
Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
|
| Experimental: Arm 3 GSK1265744 60 mg In the Induction Phase subjects will receive oral tablets of GSK1265744 60 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 60 mg + Rilpivirine 25 mg once daily from Week 24 to Week 96. |
Drug: GSK1265744 60 mg
GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Drug: Rilpivirine 25 mg
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
|
| Active Comparator: Arm 4 Efavirenz 600 mg In the Induction Phase and Maintenance Phase subjects will receive oral tablets of Efavirenz 600 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine). |
Drug: Efavirenz 600 mg
Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm [Week 48]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.
Secondary Outcome Measures
- Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
- Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.
- Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
- Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.
- Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324]
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.
- Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit [Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324]
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
- Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease [Up to Week 324]
HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
- Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96]
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.
- Change From Baseline in CD4+ Cell Count Over Time by Visit [Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324]
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
- Number of Participants With Treatment Emergent Phenotypic Resistance [Up to Week 324]
Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.
- Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance [Up to Week 324]
Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.
- Number of Participants With Adherence to Study Treatment [Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312]
Number of participants with >=90% adherence to study treatment based on pill count is summarized.
- Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase [Week 16 and Week 24]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
- Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase [Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase [Week 24 to Week 96]
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
- Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase [Week 24 to Week 96]
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
- Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase [Week 24 to Week 96]
Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
- Number of Participants With AEs and SAEs Over Time [Up to Week 324]
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
- Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time [Up to Week 324]
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
- Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time [Up to Week 324]
Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
- Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 [Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96]
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed.
- Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96]
Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed.
- Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 [Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96]
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed.
- Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96]
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed.
- Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 [Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96]
Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed.
- Change From Baseline in ALT, AST and CK Over Time by Visit [Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324]
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
- Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit [Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324]
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
- Change From Baseline in Estimated Creatinine Clearance Over Time by Visit [Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264]
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
- Change From Baseline in Hemoglobin Level Over Time by Visit [Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324]
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
- Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit [Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324]
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
- Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events [Up to Week 324]
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings [Up to Week 324]
Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented.
- Number of Participants With AEs and SAEs-Induction Phase [Up to Week 24]
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia.
- Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase [Up to Week 24]
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
- Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase [Up to Week 24]
Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
- Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase [Up to Week 24]
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
- Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase [Week 24 to Week 96]
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
- Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 [pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2]
Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data
- Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 [pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2]
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
- Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 [pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2]
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
- AUC(0 to Tau) for Rilpivirine [pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36]
Data was not collected for analysis of rilpivirine PK parameters.
- Cmax for Rilpivirine [pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36]
Data was not collected for analysis of rilpivirine PK parameters.
- Ctau for Rilpivirine [pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36]
Data was not collected for analysis of rilpivirine PK parameters.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
HIV-1 infected male or female subjects >= 18 years of age
-
Screening plasma HIV-1 RNA >=1000 c/mL
-
CD4+ cell count >=200 cells/millimeter (mm)^3
-
ART-naive defined as having =<10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
-
Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study
Exclusion Criteria:
-
Any evidence at screening of an active Centers for Disease and Prevention Control (CDC) Category C disease
-
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
-
History of ongoing or clinically relevant hepatitis within the previous 6 months, and subjects with moderate to severe hepatic impairment will be excluded
-
Women who are breastfeeding
-
Subject, who in the investigator's judgment, poses a significant suicide risk
-
Any clinically significant finding on screening or baseline electrocardiograph (ECG)
-
The presence of any specific laboratory abnormalities at Screening
-
History of cardiac disease
-
Clinically relevant pancreatitis
-
Subjects who are unlikely to complete the dosing schedule due to a pre-existing physical or mental condition
-
Any condition which impairs the absorption, distribution, metabolism or excretion of the investigational product
-
Any evidence of primary resistance based upon the presence of a major resistance associated mutation in the Screening HIV genotype, or any historical genotype
-
Treatment with any protocol-specified excluded medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Birmingham | Alabama | United States | 35294 |
| 2 | GSK Investigational Site | Phoenix | Arizona | United States | 85015 |
| 3 | GSK Investigational Site | Little Rock | Arkansas | United States | 72207 |
| 4 | GSK Investigational Site | Bakersfield | California | United States | 93301 |
| 5 | GSK Investigational Site | Beverly Hills | California | United States | 90211 |
| 6 | GSK Investigational Site | Long Beach | California | United States | 90813 |
| 7 | GSK Investigational Site | Los Angeles | California | United States | 90069 |
| 8 | GSK Investigational Site | San Francisco | California | United States | 94115 |
| 9 | GSK Investigational Site | Denver | Colorado | United States | 80209 |
| 10 | GSK Investigational Site | Washington | District of Columbia | United States | 20007 |
| 11 | GSK Investigational Site | Washington | District of Columbia | United States | 20037 |
| 12 | GSK Investigational Site | Fort Lauderdale | Florida | United States | 33308 |
| 13 | GSK Investigational Site | Fort Lauderdale | Florida | United States | 33316 |
| 14 | GSK Investigational Site | Fort Pierce | Florida | United States | 34982 |
| 15 | GSK Investigational Site | Miami | Florida | United States | 33137 |
| 16 | GSK Investigational Site | Oakland Park | Florida | United States | 33309 |
| 17 | GSK Investigational Site | Orlando | Florida | United States | 32803 |
| 18 | GSK Investigational Site | West Palm Beach | Florida | United States | 33407 |
| 19 | GSK Investigational Site | Atlanta | Georgia | United States | 30339 |
| 20 | GSK Investigational Site | Augusta | Georgia | United States | 30912 |
| 21 | GSK Investigational Site | Macon | Georgia | United States | 31201 |
| 22 | GSK Investigational Site | Savannah | Georgia | United States | 31401 |
| 23 | GSK Investigational Site | Indianapolis | Indiana | United States | 46202 |
| 24 | GSK Investigational Site | Boston | Massachusetts | United States | 02111 |
| 25 | GSK Investigational Site | Minneapolis | Minnesota | United States | 55415 |
| 26 | GSK Investigational Site | Kansas City | Missouri | United States | 64111 |
| 27 | GSK Investigational Site | Omaha | Nebraska | United States | 68198 |
| 28 | GSK Investigational Site | Las Vegas | Nevada | United States | 89106 |
| 29 | GSK Investigational Site | Hillsborough | New Jersey | United States | 08844 |
| 30 | GSK Investigational Site | Neptune | New Jersey | United States | 07753 |
| 31 | GSK Investigational Site | Albany | New York | United States | 12209 |
| 32 | GSK Investigational Site | Buffalo | New York | United States | 14201 |
| 33 | GSK Investigational Site | New York | New York | United States | 10065 |
| 34 | GSK Investigational Site | Valhalla | New York | United States | 10595 |
| 35 | GSK Investigational Site | Chapel Hill | North Carolina | United States | 27599 |
| 36 | GSK Investigational Site | Providence | Rhode Island | United States | 02906 |
| 37 | GSK Investigational Site | Charleston | South Carolina | United States | 29425 |
| 38 | GSK Investigational Site | Austin | Texas | United States | 78751 |
| 39 | GSK Investigational Site | Dallas | Texas | United States | 75246 |
| 40 | GSK Investigational Site | Annandale | Virginia | United States | 22003 |
| 41 | GSK Investigational Site | Vancouver | British Columbia | Canada | V6Z 2C7 |
| 42 | GSK Investigational Site | Vancouver | British Columbia | Canada | V6Z 2T1 |
| 43 | GSK Investigational Site | Toronto | Ontario | Canada | M4N 3M5 |
| 44 | GSK Investigational Site | Toronto | Ontario | Canada | M4T 3A7 |
| 45 | GSK Investigational Site | Toronto | Ontario | Canada | M5G 1K2 |
| 46 | GSK Investigational Site | Montreal | Quebec | Canada | H2L 4E9 |
| 47 | GSK Investigational Site | Montreal | Quebec | Canada | H2L 4P9 |
| 48 | GSK Investigational Site | Montreal | Quebec | Canada | H3A 1T1 |
Sponsors and Collaborators
- ViiV Healthcare
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, ViiV Healthcare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01641809
Other Study ID Numbers:
- 116482
First Posted:
Jul 17, 2012
Last Update Posted:
Jan 30, 2020
Last Verified:
Jan 1, 2020
Keywords provided by ViiV Healthcare
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This was a multicenter, two part study in human immunodeficiency virus-1 (HIV-1) infected antiretroviral therapy (ART) naïve adult participants conducted across 48 sites in the United States (US) and Canada. |
|---|---|
| Pre-assignment Detail | A total of 324 participants were screened, of which 80 failed screening and 244 participants were randomized to one of the four treatment arms in a ratio of 1:1:1:1. Of the 244 randomized participants, only 243 received atleast one dose of study treatment and comprised the Intent-to-Treat-Exposed (ITT-E) Population. |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Period Title: Induction Phase (Day 1 to Week 24) | ||||
| STARTED | 60 | 60 | 61 | 62 |
| COMPLETED | 52 | 53 | 55 | 47 |
| NOT COMPLETED | 8 | 7 | 6 | 15 |
| Period Title: Induction Phase (Day 1 to Week 24) | ||||
| STARTED | 52 | 53 | 55 | 47 |
| COMPLETED | 46 | 48 | 52 | 41 |
| NOT COMPLETED | 6 | 5 | 3 | 6 |
| Period Title: Induction Phase (Day 1 to Week 24) | ||||
| STARTED | 46 | 47 | 51 | 0 |
| COMPLETED | 30 | 35 | 43 | 0 |
| NOT COMPLETED | 16 | 12 | 8 | 0 |
Baseline Characteristics
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. | Total of all reporting groups |
| Overall Participants | 60 | 60 | 61 | 62 | 243 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
34.0
(9.91)
|
34.4
(10.24)
|
36.2
(10.15)
|
35.6
(12.30)
|
35.1
(10.68)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
3
5%
|
2
3.3%
|
4
6.6%
|
1
1.6%
|
10
4.1%
|
| Male |
57
95%
|
58
96.7%
|
57
93.4%
|
61
98.4%
|
233
95.9%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| African American (Af Am)/African Heritage (Her) |
21
35%
|
17
28.3%
|
18
29.5%
|
20
32.3%
|
76
31.3%
|
| American Indian or Alaskan Native (Nat) |
0
0%
|
0
0%
|
2
3.3%
|
2
3.2%
|
4
1.6%
|
| Asian-Central/South Asian Her |
1
1.7%
|
1
1.7%
|
1
1.6%
|
0
0%
|
3
1.2%
|
| Asian-Japanese/East Asian/South East Asian Her |
0
0%
|
1
1.7%
|
2
3.3%
|
0
0%
|
3
1.2%
|
| White |
37
61.7%
|
39
65%
|
36
59%
|
39
62.9%
|
151
62.1%
|
| Af Am/Af Her and Asian and White |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
1
0.4%
|
| Af Am/Af Her & Nat Hawaiian/other Pacific islander |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
1
0.4%
|
| Af Am/Af Her & White |
0
0%
|
2
3.3%
|
0
0%
|
0
0%
|
2
0.8%
|
| American Indian or Alaskan Native & White |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
| Asian & White |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
1
0.4%
|
Outcome Measures
| Title | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm |
|---|---|
| Description | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Number (95% Confidence Interval) [Percentage of participants] |
80
133.3%
|
80
133.3%
|
87
142.6%
|
71
114.5%
|
| Title | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm |
|---|---|
| Description | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 2 |
87
145%
|
80
133.3%
|
84
137.7%
|
68
109.7%
|
| Week 4 |
93
155%
|
93
155%
|
93
152.5%
|
68
109.7%
|
| Week 8 |
93
155%
|
92
153.3%
|
92
150.8%
|
79
127.4%
|
| Week 12 |
90
150%
|
85
141.7%
|
89
145.9%
|
73
117.7%
|
| Week 16 |
93
155%
|
87
145%
|
93
152.5%
|
81
130.6%
|
| Week 24 |
93
155%
|
87
145%
|
92
150.8%
|
79
127.4%
|
| Week 26 |
80
133.3%
|
80
133.3%
|
87
142.6%
|
71
114.5%
|
| Week 28 |
85
141.7%
|
83
138.3%
|
85
139.3%
|
73
117.7%
|
| Week 32 |
87
145%
|
85
141.7%
|
89
145.9%
|
73
117.7%
|
| Week 36 |
87
145%
|
85
141.7%
|
90
147.5%
|
73
117.7%
|
| Week 40 |
87
145%
|
85
141.7%
|
90
147.5%
|
73
117.7%
|
| Week 48 |
83
138.3%
|
85
141.7%
|
89
145.9%
|
73
117.7%
|
| Week 60 |
80
133.3%
|
77
128.3%
|
87
142.6%
|
71
114.5%
|
| Week 72 |
77
128.3%
|
75
125%
|
85
139.3%
|
68
109.7%
|
| Week 84 |
77
128.3%
|
77
128.3%
|
85
139.3%
|
68
109.7%
|
| Week 96 |
75
125%
|
77
128.3%
|
85
139.3%
|
65
104.8%
|
| Title | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis |
|---|---|
| Description | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Baseline; n=60, 60, 61, 62 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 2; n=57, 56, 59, 59 |
91
151.7%
|
86
143.3%
|
86
141%
|
71
114.5%
|
| Week 4; n=58, 57, 59, 57 |
97
161.7%
|
98
163.3%
|
97
159%
|
74
119.4%
|
| Week 8; n=59, 56, 57, 55 |
95
158.3%
|
98
163.3%
|
98
160.7%
|
91
146.8%
|
| Week 12; n=58, 52, 57, 51 |
97
161.7%
|
100
166.7%
|
98
160.7%
|
92
148.4%
|
| Week 16; n=57, 54, 57, 52 |
98
163.3%
|
100
166.7%
|
100
163.9%
|
96
154.8%
|
| Week 20; n=56, 54, 56, 47 |
100
166.7%
|
100
166.7%
|
100
163.9%
|
100
161.3%
|
| Week 24; n=56, 53, 56, 48 |
100
166.7%
|
100
166.7%
|
100
163.9%
|
100
161.3%
|
| Week 26; n=48, 50, 53, 44 |
100
166.7%
|
100
166.7%
|
100
163.9%
|
100
161.3%
|
| Week 28; n=51, 52, 52, 45 |
100
166.7%
|
100
166.7%
|
100
163.9%
|
100
161.3%
|
| Week 32; n=52, 53, 55, 45 |
100
166.7%
|
100
166.7%
|
98
160.7%
|
100
161.3%
|
| Week 36; n=52, 53, 55, 45 |
100
166.7%
|
100
166.7%
|
100
163.9%
|
100
161.3%
|
| Week 40; n=52, 53, 55, 45 |
100
166.7%
|
100
166.7%
|
100
163.9%
|
100
161.3%
|
| Week 48; n=51, 53, 54, 44 |
98
163.3%
|
98
163.3%
|
100
163.9%
|
100
161.3%
|
| Week 60; n=48, 48, 53, 44 |
96
160%
|
100
166.7%
|
100
163.9%
|
98
158.1%
|
| Week 72; n=47, 48, 52, 42 |
98
163.3%
|
96
160%
|
100
163.9%
|
100
161.3%
|
| Week 84; n=46, 48, 52, 42 |
100
166.7%
|
98
163.3%
|
100
163.9%
|
100
161.3%
|
| Week 96; n=45, 48, 52, 40 |
96
160%
|
100
166.7%
|
100
163.9%
|
100
161.3%
|
| Title | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm |
|---|---|
| Description | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 2 |
48
80%
|
50
83.3%
|
51
83.6%
|
13
21%
|
| Week 4 |
80
133.3%
|
78
130%
|
70
114.8%
|
24
38.7%
|
| Week 8 |
90
150%
|
83
138.3%
|
87
142.6%
|
48
77.4%
|
| Week 12 |
88
146.7%
|
75
125%
|
82
134.4%
|
61
98.4%
|
| Week 16 |
90
150%
|
83
138.3%
|
87
142.6%
|
74
119.4%
|
| Week 24 |
87
145%
|
85
141.7%
|
87
142.6%
|
74
119.4%
|
| Week 26 |
78
130%
|
75
125%
|
85
139.3%
|
66
106.5%
|
| Week 28 |
85
141.7%
|
78
130%
|
85
139.3%
|
69
111.3%
|
| Week 32 |
83
138.3%
|
80
133.3%
|
87
142.6%
|
69
111.3%
|
| Week 36 |
85
141.7%
|
82
136.7%
|
85
139.3%
|
71
114.5%
|
| Week 40 |
83
138.3%
|
82
136.7%
|
85
139.3%
|
68
109.7%
|
| Week 48 |
80
133.3%
|
80
133.3%
|
87
142.6%
|
71
114.5%
|
| Week 60 |
78
130%
|
73
121.7%
|
85
139.3%
|
68
109.7%
|
| Week 72 |
72
120%
|
73
121.7%
|
85
139.3%
|
68
109.7%
|
| Week 84 |
72
120%
|
75
125%
|
85
139.3%
|
68
109.7%
|
| Week 96 |
68
113.3%
|
75
125%
|
84
137.7%
|
63
101.6%
|
| Week 108 |
68
113.3%
|
72
120%
|
80
131.1%
|
0
0%
|
| Week 120 |
65
108.3%
|
73
121.7%
|
80
131.1%
|
0
0%
|
| Week 132 |
62
103.3%
|
70
116.7%
|
80
131.1%
|
0
0%
|
| Week 144 |
58
96.7%
|
67
111.7%
|
77
126.2%
|
0
0%
|
| Week 156 |
58
96.7%
|
63
105%
|
80
131.1%
|
0
0%
|
| Week 168 |
57
95%
|
65
108.3%
|
75
123%
|
0
0%
|
| Week 180 |
58
96.7%
|
67
111.7%
|
75
123%
|
0
0%
|
| Week 192 |
57
95%
|
65
108.3%
|
74
121.3%
|
0
0%
|
| Week 204 |
55
91.7%
|
62
103.3%
|
75
123%
|
0
0%
|
| Week 216 |
55
91.7%
|
63
105%
|
77
126.2%
|
0
0%
|
| Week 228 |
53
88.3%
|
63
105%
|
75
123%
|
0
0%
|
| Week 240 |
50
83.3%
|
62
103.3%
|
74
121.3%
|
0
0%
|
| Week 252 |
52
86.7%
|
62
103.3%
|
75
123%
|
0
0%
|
| Week 264 |
53
88.3%
|
62
103.3%
|
75
123%
|
0
0%
|
| Week 276 |
52
86.7%
|
62
103.3%
|
70
114.8%
|
0
0%
|
| Week 288 |
50
83.3%
|
62
103.3%
|
74
121.3%
|
0
0%
|
| Week 300 |
52
86.7%
|
60
100%
|
70
114.8%
|
0
0%
|
| Week 312 |
52
86.7%
|
52
86.7%
|
70
114.8%
|
0
0%
|
| Title | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis |
|---|---|
| Description | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Baseline; n=60, 60, 61, 62 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 2; n=57, 56, 59, 59 |
51
85%
|
54
90%
|
53
86.9%
|
14
22.6%
|
| Week 4; n=58, 57, 59, 57 |
83
138.3%
|
82
136.7%
|
73
119.7%
|
26
41.9%
|
| Week 8; n=59, 56, 57, 55 |
92
153.3%
|
89
148.3%
|
93
152.5%
|
55
88.7%
|
| Week 12; n=58, 52, 57, 51 |
95
158.3%
|
88
146.7%
|
91
149.2%
|
76
122.6%
|
| Week 16; n=57, 54, 57, 52 |
95
158.3%
|
94
156.7%
|
93
152.5%
|
87
140.3%
|
| Week 20; n=56, 54, 56, 47 |
91
151.7%
|
98
163.3%
|
98
160.7%
|
91
146.8%
|
| Week 24; n=56, 53, 56, 48 |
93
155%
|
98
163.3%
|
95
155.7%
|
96
154.8%
|
| Week 26; n=48, 50, 53, 44 |
98
163.3%
|
94
156.7%
|
98
160.7%
|
93
150%
|
| Week 28; n=51, 52, 52, 45 |
100
166.7%
|
94
156.7%
|
100
163.9%
|
96
154.8%
|
| Week 32; n=52, 53, 55, 45 |
96
160%
|
94
156.7%
|
96
157.4%
|
96
154.8%
|
| Week 36; n=52, 53, 55, 45 |
98
163.3%
|
96
160%
|
95
155.7%
|
98
158.1%
|
| Week 40; n=52, 53, 55, 45 |
96
160%
|
96
160%
|
95
155.7%
|
93
150%
|
| Week 48; n=51, 53, 54, 44 |
92
153.3%
|
92
153.3%
|
98
160.7%
|
98
158.1%
|
| Week 60; n=48, 48, 53, 44 |
94
156.7%
|
96
160%
|
98
160.7%
|
95
153.2%
|
| Week 72; n=47, 48, 52, 42 |
91
151.7%
|
92
153.3%
|
100
163.9%
|
100
161.3%
|
| Week 84; n=46, 48, 52, 42 |
91
151.7%
|
94
156.7%
|
100
163.9%
|
100
161.3%
|
| Week 96; n=45, 48, 52, 40 |
89
148.3%
|
98
163.3%
|
98
160.7%
|
98
158.1%
|
| Week 108; n=43, 46, 49, 0 |
95
158.3%
|
96
160%
|
100
163.9%
|
|
| Week 120; n=41, 46, 49, 0 |
95
158.3%
|
100
166.7%
|
98
160.7%
|
|
| Week 132; n=40, 46, 49, 0 |
95
158.3%
|
96
160%
|
100
163.9%
|
|
| Week 144; n=37, 45, 47, 0 |
92
153.3%
|
93
155%
|
98
160.7%
|
|
| Week 156; n=37, 42, 49, 0 |
95
158.3%
|
95
158.3%
|
98
160.7%
|
|
| Week 168; n=35, 43, 47, 0 |
94
156.7%
|
95
158.3%
|
98
160.7%
|
|
| Week 180; n=36, 41, 47, 0 |
97
161.7%
|
100
166.7%
|
98
160.7%
|
|
| Week 192; n=36, 40, 47, 0 |
94
156.7%
|
100
166.7%
|
96
157.4%
|
|
| Week 204; n=34, 39, 47, 0 |
97
161.7%
|
97
161.7%
|
98
160.7%
|
|
| Week 216; n=33, 39, 47, 0 |
100
166.7%
|
100
166.7%
|
98
160.7%
|
|
| Week 228; n=32, 39, 47, 0 |
100
166.7%
|
100
166.7%
|
98
160.7%
|
|
| Week 240; n=31, 39, 45, 0 |
97
161.7%
|
97
161.7%
|
100
163.9%
|
|
| Week 252; n=31, 38, 47, 0 |
100
166.7%
|
97
161.7%
|
98
160.7%
|
|
| Week 264; n=32, 38, 47, 0 |
100
166.7%
|
100
166.7%
|
98
160.7%
|
|
| Week 276; n=31, 38, 45, 0 |
100
166.7%
|
100
166.7%
|
96
157.4%
|
|
| Week 288; n=30, 38, 45, 0 |
100
166.7%
|
100
166.7%
|
100
163.9%
|
|
| Week 300; n=31, 37, 44, 0 |
97
161.7%
|
100
166.7%
|
95
155.7%
|
|
| Week 312; n=31, 33, 43, 0 |
100
166.7%
|
97
161.7%
|
100
163.9%
|
|
| Week 324; n=3, 4, 3, 0 |
100
166.7%
|
100
166.7%
|
100
163.9%
|
| Title | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit |
|---|---|
| Description | Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Baseline; n=60, 60, 61, 62 |
4.424
(0.5834)
|
4.270
(0.6359)
|
4.428
(0.6418)
|
4.290
(0.6683)
|
| Week 2; n=57, 56, 59, 59 |
1.883
(0.4551)
|
1.984
(0.5786)
|
1.939
(0.5071)
|
2.415
(0.5717)
|
| Week 4; n=58, 57, 59, 57 |
1.706
(0.3245)
|
1.731
(0.4141)
|
1.725
(0.2750)
|
2.201
(0.5780)
|
| Week 8; n=59, 56, 57, 55 |
1.695
(0.4114)
|
1.666
(0.3676)
|
1.666
(0.3926)
|
1.950
(0.5636)
|
| Week 12; n=58, 52, 57, 51 |
1.643
(0.2506)
|
1.618
(0.0786)
|
1.641
(0.2033)
|
1.758
(0.4082)
|
| Week 16; n=57, 54, 57, 52 |
1.619
(0.1418)
|
1.602
(0.0354)
|
1.616
(0.0956)
|
1.697
(0.3277)
|
| Week 20; n=56, 54, 56, 47 |
1.623
(0.1175)
|
1.596
(0.0346)
|
1.599
(0.0591)
|
1.649
(0.1962)
|
| Week 24; n=56, 53, 56, 48 |
1.615
(0.1010)
|
1.597
(0.0360)
|
1.603
(0.0532)
|
1.610
(0.0902)
|
| Week 26; n=48, 50, 53, 44 |
1.595
(0.0270)
|
1.602
(0.0434)
|
1.594
(0.0194)
|
1.610
(0.0742)
|
| Week 28; n=51, 52, 52, 45 |
1.591
(0.0000)
|
1.607
(0.0565)
|
1.591
(0.0000)
|
1.600
(0.0451)
|
| Week 32; n=52, 53, 55, 45 |
1.609
(0.0955)
|
1.620
(0.1277)
|
1.618
(0.1742)
|
1.614
(0.1022)
|
| Week 36; n=52, 53, 55, 45 |
1.604
(0.0782)
|
1.610
(0.1070)
|
1.606
(0.0722)
|
1.607
(0.1068)
|
| Week 40; n=52, 53, 55, 45 |
1.612
(0.1206)
|
1.618
(0.1214)
|
1.608
(0.0752)
|
1.607
(0.0650)
|
| Week 48; n=51, 53, 54, 44 |
1.686
(0.4077)
|
1.654
(0.3673)
|
1.598
(0.0508)
|
1.596
(0.0247)
|
| Week 60; n=48, 48, 53, 44 |
1.648
(0.2643)
|
1.598
(0.0300)
|
1.594
(0.0205)
|
1.657
(0.3948)
|
| Week 72; n=47, 48, 52, 42 |
1.625
(0.1584)
|
1.697
(0.4705)
|
1.591
(0.0000)
|
1.592
(0.0065)
|
| Week 84; n=46, 48, 52, 42 |
1.645
(0.1838)
|
1.643
(0.2896)
|
1.592
(0.0059)
|
1.591
(0.0017)
|
| Week 96; n=45, 48, 52, 40 |
1.681
(0.2783)
|
1.603
(0.0861)
|
1.596
(0.0227)
|
1.598
(0.0467)
|
| Week 108; n=43, 46, 49, 0 |
1.634
(0.1979)
|
1.609
(0.0885)
|
1.591
(0.0000)
|
|
| Week 120; n=41, 46, 49, 0 |
1.638
(0.2216)
|
1.591
(0.0000)
|
1.618
(0.1884)
|
|
| Week 132; n=40, 46, 49, 0 |
1.646
(0.2491)
|
1.631
(0.2097)
|
1.591
(0.0000)
|
|
| Week 144; n=37, 45, 47, 0 |
1.682
(0.4027)
|
1.698
(0.5940)
|
1.630
(0.2656)
|
|
| Week 156; n=37, 42, 49, 0 |
1.634
(0.1850)
|
1.603
(0.0520)
|
1.619
(0.1833)
|
|
| Week 168; n=35, 43, 47, 0 |
1.665
(0.3351)
|
1.642
(0.2908)
|
1.603
(0.0810)
|
|
| Week 180; n=36, 41, 47, 0 |
1.613
(0.1324)
|
1.591
(0.0000)
|
1.600
(0.0584)
|
|
| Week 192; n=36, 40, 47, 0 |
1.689
(0.4119)
|
1.591
(0.0000)
|
1.699
(0.6971)
|
|
| Week 204; n=34, 39, 47, 0 |
1.628
(0.2162)
|
1.595
(0.0252)
|
1.634
(0.2936)
|
|
| Week 216; n=33, 39, 47, 0 |
1.591
(0.0000)
|
1.592
(0.0052)
|
1.634
(0.2948)
|
|
| Week 228; n=32, 39, 47, 0 |
1.591
(0.0000)
|
1.591
(0.0000)
|
1.625
(0.2351)
|
|
| Week 240; n=31, 39, 45, 0 |
1.596
(0.0268)
|
1.601
(0.0465)
|
1.591
(0.0000)
|
|
| Week 252; n=31, 38, 47, 0 |
1.591
(0.0000)
|
1.599
(0.0461)
|
1.593
(0.0157)
|
|
| Week 264; n=32, 38, 47, 0 |
1.591
(0.0000)
|
1.591
(0.0000)
|
1.617
(0.1788)
|
|
| Week 276; n=31, 38, 45, 0 |
1.591
(0.0000)
|
1.591
(0.0000)
|
1.618
(0.1398)
|
|
| Week 288; n=30, 38, 45, 0 |
1.591
(0.000)
|
1.592
(0.0052)
|
1.591
(0.0000)
|
|
| Week 300; n=31, 37, 44, 0 |
1.601
(0.0551)
|
1.591
(0.0000)
|
1.625
(0.1753)
|
|
| Week 312; n=31, 33, 43, 0 |
1.597
(0.0214)
|
1.600
(0.0494)
|
1.591
(0.0000)
|
|
| Week 324; n=3, 4, 3, 0 |
1.591
(0.0000)
|
1.591
(0.0000)
|
1.591
(0.0000)
|
| Title | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit |
|---|---|
| Description | Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Time Frame | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Week 2; n=57, 56, 59, 59 |
-2.534
(0.4175)
|
-2.306
(0.5937)
|
-2.504
(0.4311)
|
-1.875
(0.4273)
|
| Week 4; n=58, 57, 59, 57 |
-2.731
(0.4158)
|
-2.550
(0.6300)
|
-2.718
(0.4981)
|
-2.092
(0.4866)
|
| Week 8; n=59, 56, 57, 55 |
-2.733
(0.6374)
|
-2.611
(0.6938)
|
-2.741
(0.7034)
|
-2.344
(0.6765)
|
| Week 12; n=58, 52, 57, 51 |
-2.793
(0.5574)
|
-2.634
(0.6308)
|
-2.790
(0.6515)
|
-2.533
(0.6580)
|
| Week 16; n=57, 54, 57, 52 |
-2.823
(0.5118)
|
-2.659
(0.6363)
|
-2.815
(0.6170)
|
-2.602
(0.6698)
|
| Week 20; n=56, 54, 56, 47 |
-2.823
(0.5329)
|
-2.665
(0.6418)
|
-2.834
(0.6250)
|
-2.666
(0.6512)
|
| Week 24; n=56, 53, 56, 48 |
-2.831
(0.5465)
|
-2.659
(0.6488)
|
-2.830
(0.6304)
|
-2.694
(0.6843)
|
| Week 26; n=48, 50, 53, 44 |
-2.788
(0.5023)
|
-2.662
(0.6670)
|
-2.792
(0.6014)
|
-2.733
(0.6879)
|
| Week 28; n=51, 52, 52, 45 |
-2.784
(0.4944)
|
-2.663
(0.6356)
|
-2.791
(0.5831)
|
-2.714
(0.6873)
|
| Week 32; n=52, 53, 55, 45 |
-2.763
(0.5164)
|
-2.636
(0.6598)
|
-2.781
(0.6146)
|
-2.672
(0.6812)
|
| Week 36; n=52, 53, 55, 45 |
-2.768
(0.5000)
|
-2.646
(0.6786)
|
-2.792
(0.5803)
|
-2.679
(0.6776)
|
| Week 40; n=52, 53, 55, 45 |
-2.760
(0.5143)
|
-2.638
(0.6581)
|
-2.790
(0.5736)
|
-2.679
(0.6817)
|
| Week 48; n=51, 53, 54, 44 |
-2.682
(0.6637)
|
-2.602
(0.7855)
|
-2.799
(0.5946)
|
-2.676
(0.6773)
|
| Week 60; n=48, 48, 53, 44 |
-2.729
(0.6405)
|
-2.613
(0.6068)
|
-2.787
(0.5920)
|
-2.615
(0.8875)
|
| Week 72; n=47, 48, 52, 42 |
-2.745
(0.5229)
|
-2.514
(0.7487)
|
-2.783
(0.6009)
|
-2.738
(0.6415)
|
| Week 84; n=46, 48, 52, 42 |
-2.722
(0.5650)
|
-2.568
(0.7144)
|
-2.782
(0.5994)
|
-2.739
(0.6431)
|
| Week 96; n=45, 48, 52, 40 |
-2.670
(0.5277)
|
-2.608
(0.6342)
|
-2.778
(0.5943)
|
-2.731
(0.6586)
|
| Week 108; n=43, 46, 49, 0 |
-2.723
(0.5396)
|
-2.632
(0.6265)
|
-2.743
(0.5851)
|
|
| Week 120; n=41, 46, 49, 0 |
-2.712
(0.5477)
|
-2.650
(0.6137)
|
-2.717
(0.6180)
|
|
| Week 132; n=40, 46, 49, 0 |
-2.705
(0.5504)
|
-2.610
(0.6718)
|
-2.743
(0.5851)
|
|
| Week 144; n=37, 45, 47, 0 |
-2.690
(0.6615)
|
-2.555
(0.9008)
|
-2.703
(0.6903)
|
|
| Week 156; n=37, 42, 49, 0 |
-2.737
(0.5476)
|
-2.645
(0.6129)
|
-2.716
(0.6309)
|
|
| Week 168; n=35, 43, 47, 0 |
-2.680
(0.6170)
|
-2.592
(0.7138)
|
-2.700
(0.5907)
|
|
| Week 180; n=36, 41, 47, 0 |
-2.747
(0.4984)
|
-2.628
(0.6251)
|
-2.767
(0.5672)
|
|
| Week 192; n=36, 40, 47, 0 |
-2.671
(0.6656)
|
-2.641
(0.6272)
|
-2.667
(0.8708)
|
|
| Week 204; n=34, 39, 47, 0 |
-2.750
(0.5359)
|
-2.632
(0.6353)
|
-2.718
(0.7294)
|
|
| Week 216; n=33, 39, 47, 0 |
-2.787
(0.4956)
|
-2.636
(0.6337)
|
-2.718
(0.6660)
|
|
| Week 228; n=32, 39, 47, 0 |
-2.770
(0.4940)
|
-2.636
(0.6346)
|
-2.726
(0.6757)
|
|
| Week 240; n=31, 39, 45, 0 |
-2.798
(0.4923)
|
-2.627
(0.6181)
|
-2.736
(0.5861)
|
|
| Week 252; n=31, 38, 47, 0 |
-2.787
(0.5092)
|
-2.601
(0.6209)
|
-2.758
(0.5875)
|
|
| Week 264; n=32, 38, 47, 0 |
-2.780
(0.5022)
|
-2.659
(0.6264)
|
-2.734
(0.6213)
|
|
| Week 276; n=31, 38, 45, 0 |
-2.786
(0.5095)
|
-2.659
(0.6264)
|
-2.764
(0.6002)
|
|
| Week 288; n=30, 38, 45, 0 |
-2.768
(0.5083)
|
-2.659
(0.6246)
|
-2.775
(0.5984)
|
|
| Week 300; n=31, 37, 44, 0 |
-2.776
(0.5062)
|
-2.664
(0.6344)
|
-2.730
(0.6786)
|
|
| Week 312; n=31, 33, 43, 0 |
-2.780
(0.5085)
|
-2.569
(0.6037)
|
-2.789
(0.5825)
|
|
| Week 324; n=3, 4, 3, 0 |
-2.488
(0.1409)
|
-2.215
(0.4624)
|
-2.438
(0.5904)
|
| Title | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease |
|---|---|
| Description | HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death. |
| Time Frame | Up to Week 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| CDC Class A to CDC Class C |
1
1.7%
|
1
1.7%
|
0
0%
|
0
0%
|
| CDC Class B to CDC Class C |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CDC Class C to new CDC Class C |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CDC Class A, B or C to Death |
0
0%
|
1
1.7%
|
1
1.6%
|
0
0%
|
| Title | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 |
|---|---|
| Description | CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Baseline; n=60, 60, 61, 62 |
445.5
(155.60)
|
444.9
(190.98)
|
459.0
(170.64)
|
456.5
(196.11)
|
| Week 2; n=57, 56, 59, 59 |
544.0
(197.54)
|
525.1
(181.29)
|
549.3
(206.68)
|
487.0
(222.84)
|
| Week 4; n=58, 57, 59, 57 |
580.5
(230.40)
|
522.0
(205.80)
|
545.8
(196.79)
|
509.9
(198.21)
|
| Week 8; n=58, 56, 57, 55 |
576.6
(196.55)
|
555.2
(210.92)
|
544.3
(176.01)
|
531.4
(175.95)
|
| Week 12; n=58, 53, 57, 51 |
588.4
(208.15)
|
599.0
(226.06)
|
596.6
(181.00)
|
564.3
(222.99)
|
| Week 16; n=57, 54, 57, 52 |
608.3
(200.34)
|
595.8
(197.47)
|
599.7
(166.77)
|
594.4
(212.63)
|
| Week 20; n=56, 54, 56, 49 |
607.3
(204.87)
|
607.4
(199.27)
|
636.6
(225.04)
|
607.7
(186.36)
|
| Week 24; n=56, 53, 56, 47 |
614.6
(194.13)
|
626.5
(210.63)
|
658.0
(253.19)
|
599.5
(219.52)
|
| Week 26; n=48, 50, 53, 45 |
632.8
(210.93)
|
629.5
(207.34)
|
645.8
(188.61)
|
625.7
(196.46)
|
| Week 28; n=49, 52, 52, 45 |
652.2
(225.32)
|
635.9
(217.52)
|
653.3
(261.11)
|
635.7
(224.72)
|
| Week 32; n=52, 53, 55, 45 |
638.1
(192.54)
|
650.8
(209.66)
|
665.2
(246.84)
|
663.8
(257.25)
|
| Week 36; n=52, 53, 55, 45 |
638.7
(198.05)
|
658.6
(226.51)
|
720.3
(257.85)
|
651.5
(212.15)
|
| Week 40; n=52, 53, 55, 45 |
650.2
(218.40)
|
658.5
(204.08)
|
667.6
(187.30)
|
687.9
(241.35)
|
| Week 48; n=51, 53, 54, 44 |
677.3
(219.75)
|
687.2
(227.06)
|
713.8
(215.70)
|
732.6
(273.19)
|
| Week 60; n=48, 47, 53, 44 |
668.1
(222.61)
|
720.9
(268.74)
|
719.8
(219.04)
|
733.9
(238.90)
|
| Week 72; n=47, 48, 52, 42 |
683.2
(242.75)
|
651.3
(217.19)
|
710.9
(259.89)
|
722.5
(263.47)
|
| Week 84; n=46, 48, 52, 42 |
718.3
(212.59)
|
736.9
(271.85)
|
735.0
(236.25)
|
744.7
(250.90)
|
| Week 96; n=46, 46, 52, 41 |
726.2
(272.28)
|
722.9
(246.22)
|
743.1
(242.23)
|
747.8
(263.27)
|
| Title | Change From Baseline in CD4+ Cell Count Over Time by Visit |
|---|---|
| Description | CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Time Frame | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population.Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Week 2; n=57, 56, 59, 59 |
92.6
(112.44)
|
79.5
(118.15)
|
91.7
(127.92)
|
24.8
(138.47)
|
| Week 4; n=58, 57, 59, 57 |
136.4
(157.36)
|
76.9
(107.01)
|
88.2
(110.01)
|
46.0
(106.35)
|
| Week 8; n=58, 56, 57, 55 |
129.9
(123.47)
|
117.8
(132.19)
|
90.5
(148.25)
|
65.6
(120.25)
|
| Week 12; n=58, 53, 57, 51 |
140.5
(142.86)
|
140.8
(165.02)
|
145.2
(142.24)
|
103.4
(125.39)
|
| Week 16; n=57, 54, 57, 52 |
159.3
(115.36)
|
142.2
(145.64)
|
148.3
(131.81)
|
135.5
(153.48)
|
| Week 20; n=56, 54, 56, 49 |
165.2
(146.90)
|
153.8
(150.40)
|
182.6
(142.18)
|
149.0
(117.44)
|
| Week 24; n=56, 53, 56, 47 |
172.5
(112.04)
|
180.9
(161.43)
|
204.0
(166.78)
|
143.4
(145.18)
|
| Week 26; n=48, 50, 53, 45 |
186.4
(153.99)
|
177.7
(146.84)
|
194.7
(149.66)
|
166.4
(145.11)
|
| Week 28; n=49, 52, 52, 45 |
205.0
(164.91)
|
188.1
(132.08)
|
193.3
(154.43)
|
178.2
(150.25)
|
| Week 32; n=52, 53, 55, 45 |
191.4
(151.79)
|
205.2
(145.53)
|
209.9
(157.56)
|
197.4
(170.48)
|
| Week 36; n=52, 53, 55, 45 |
192.0
(165.97)
|
213.0
(144.89)
|
265.0
(169.42)
|
185.2
(152.91)
|
| Week 40; n=52, 53, 55, 45 |
203.6
(171.74)
|
212.8
(180.38)
|
212.3
(114.67)
|
221.5
(188.99)
|
| Week 48; n=51, 53, 54, 44 |
235.1
(179.89)
|
241.6
(182.90)
|
259.0
(154.21)
|
262.5
(201.33)
|
| Week 60; n=48, 47, 53, 44 |
217.7
(152.92)
|
269.4
(188.34)
|
266.1
(156.03)
|
263.8
(181.15)
|
| Week 72; n=47, 48, 52, 42 |
232.0
(191.05)
|
201.4
(206.54)
|
254.0
(189.26)
|
257.1
(216.41)
|
| Week 84; n=46, 48, 52, 42 |
261.5
(171.65)
|
287.0
(207.10)
|
278.1
(166.11)
|
279.4
(191.30)
|
| Week 96; n=46, 46, 52, 41 |
269.4
(204.32)
|
267.5
(196.27)
|
286.2
(181.50)
|
281.7
(232.90)
|
| Week 108; n=43, 46, 49, 0 |
296.2
(215.21)
|
304.3
(195.30)
|
288.4
(184.61)
|
|
| Week 120; n=41, 46, 49, 0 |
266.1
(173.09)
|
279.3
(181.10)
|
307.2
(225.39)
|
|
| Week 132; n=40, 46, 49, 0 |
297.1
(167.59)
|
305.2
(184.98)
|
313.2
(168.30)
|
|
| Week 144; n=37, 45, 46, 0 |
330.7
(225.42)
|
308.9
(224.63)
|
322.4
(224.57)
|
|
| Week 156; n=37, 42, 49, 0 |
334.5
(213.79)
|
319.2
(182.15)
|
320.4
(187.58)
|
|
| Week 168; n=35, 43, 47, 0 |
338.1
(252.13)
|
332.4
(222.37)
|
361.3
(198.98)
|
|
| Week 180; n=36, 41, 47, 0 |
338.0
(218.72)
|
348.6
(203.73)
|
384.2
(192.86)
|
|
| Week 192; n=35, 40, 47, 0 |
300.8
(168.24)
|
351.0
(205.56)
|
342.3
(204.83)
|
|
| Week 204; n=34, 39, 47, 0 |
369.5
(196.17)
|
332.9
(179.28)
|
340.0
(191.82)
|
|
| Week 216; n=33, 39, 47, 0 |
397.0
(202.03)
|
373.4
(188.28)
|
357.8
(199.87)
|
|
| Week 228; n=32, 39, 47, 0 |
331.8
(168.64)
|
366.5
(231.25)
|
383.7
(253.17)
|
|
| Week 240; n=32, 39, 47, 0 |
356.5
(195.99)
|
395.9
(205.55)
|
408.4
(201.05)
|
|
| Week 252; n=31, 38, 47, 0 |
400.3
(183.36)
|
343.7
(196.09)
|
383.1
(217.20)
|
|
| Week 264; n=32, 38, 47, 0 |
344.4
(160.38)
|
365.0
(210.00)
|
391.8
(222.00)
|
|
| Week 276; n=31, 38, 46, 0 |
398.3
(250.45)
|
350.3
(210.98)
|
362.2
(243.30)
|
|
| Week 288; n=30, 38, 45, 0 |
411.0
(161.93)
|
383.5
(279.75)
|
337.1
(187.13)
|
|
| Week 300; n=30, 37, 44, 0 |
437.7
(196.33)
|
404.4
(239.11)
|
353.5
(200.23)
|
|
| Week 312; n=30, 34, 43, 0 |
335.0
(176.73)
|
433.0
(264.63)
|
407.0
(178.06)
|
|
| Week 324; n=3, 4, 3, 0 |
402.0
(197.55)
|
276.0
(278.28)
|
272.0
(277.44)
|
| Title | Number of Participants With Treatment Emergent Phenotypic Resistance |
|---|---|
| Description | Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures. |
| Time Frame | Up to Week 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment Phenotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 6 | 2 | 2 | 5 |
| INI, GSK1265744; Resistant; n=5, 1, 2, 2 |
2
3.3%
|
0
0%
|
1
1.6%
|
0
0%
|
| INI, GSK1265744; Sensitive; n=5, 1, 2, 2 |
3
5%
|
1
1.7%
|
1
1.6%
|
2
3.2%
|
| INI, RAL; Resistant; n=5, 1, 2, 2 |
3
5%
|
0
0%
|
1
1.6%
|
0
0%
|
| INI, RAL; Sensitive; n=5, 1, 2, 2 |
2
3.3%
|
1
1.7%
|
1
1.6%
|
2
3.2%
|
| NNRTI, DLV; Resistant; n=6, 2, 2, 5 |
3
5%
|
0
0%
|
0
0%
|
0
0%
|
| NNRTI, DLV; Sensitive; n=6, 2, 2, 5 |
3
5%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NNRTI, EFV; Resistant; n=6, 2, 2, 5 |
3
5%
|
0
0%
|
0
0%
|
0
0%
|
| NNRTI, EFV; Sensitive; n=6, 2, 2, 5 |
3
5%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NNRTI, ETR; Resistant; n=6, 2, 2, 5 |
3
5%
|
0
0%
|
0
0%
|
0
0%
|
| NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NNRTI, ETR; Sensitive; n=6, 2, 2, 5 |
3
5%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NNRTI, NVP; Resistant; n=6, 2, 2, 5 |
3
5%
|
0
0%
|
0
0%
|
0
0%
|
| NNRTI, NVP; Sensitive; n=6, 2, 2, 5 |
3
5%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NNRTI, RPV; Resistant; n=6, 2, 2, 5 |
3
5%
|
0
0%
|
0
0%
|
0
0%
|
| NNRTI, RPV; Sensitive; n=6, 2, 2, 5 |
3
5%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NRTI, 3TC; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, 3TC; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NRTI, ABC; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, ABC; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NRTI, FTC; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, FTC; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NRTI, TDF; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, TDF; Sensitive; n=6, 2, 2, 5 |
5
8.3%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NRTI, ZDV; Resistant; n=6, 2, 2, 5 |
2
3.3%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, ZDV; Sensitive; n=6, 2, 2, 5 |
4
6.7%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NRTI, d4T; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, d4T; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| NRTI, ddI; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| NRTI, ddI; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, ATV/r; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, ATV/r; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, DRV/r; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, DRV/r; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, FPV/r; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, FPV/r; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, IDV/r; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, IDV/r; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, LPV/r; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, LPV/r; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, NFV; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, NFV; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, RTV; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, RTV; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, SQV/r; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, SQV/r; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| PI, TPV/r; Resistant; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PI, TPV/r; Sensitive; n=6, 2, 2, 5 |
6
10%
|
2
3.3%
|
2
3.3%
|
5
8.1%
|
| Title | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance |
|---|---|
| Description | Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures. |
| Time Frame | Up to Week 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment Genotypic resistance Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 6 | 2 | 2 | 5 |
| Any INI mutation |
3
5%
|
0
0%
|
1
1.6%
|
0
0%
|
| Any mutation to other classes |
4
6.7%
|
0
0%
|
1
1.6%
|
0
0%
|
| Title | Number of Participants With Adherence to Study Treatment |
|---|---|
| Description | Number of participants with >=90% adherence to study treatment based on pill count is summarized. |
| Time Frame | Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population. Only participants who were dispensed and returned drug on scheduled visits were included in the analysis (represented by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 57 | 55 | 56 | 52 |
| Baseline; n=57, 55, 56, 52 |
53
88.3%
|
51
85%
|
55
90.2%
|
48
77.4%
|
| Week 4; n=54, 52, 53, 50 |
46
76.7%
|
49
81.7%
|
52
85.2%
|
44
71%
|
| Week 8; n=53, 50, 56, 48 |
49
81.7%
|
45
75%
|
53
86.9%
|
47
75.8%
|
| Week 12; n=55, 48, 53, 48 |
44
73.3%
|
40
66.7%
|
46
75.4%
|
43
69.4%
|
| Week 16; n=53, 51, 53, 44 |
44
73.3%
|
45
75%
|
50
82%
|
42
67.7%
|
| Week 20; n=51, 49, 55, 44 |
45
75%
|
40
66.7%
|
51
83.6%
|
41
66.1%
|
| Week 24; n=51, 46, 51, 43 |
47
78.3%
|
41
68.3%
|
48
78.7%
|
39
62.9%
|
| Week 28; n=49, 48, 53, 41 |
45
75%
|
46
76.7%
|
48
78.7%
|
35
56.5%
|
| Week 32; n=47, 48, 55, 41 |
46
76.7%
|
42
70%
|
52
85.2%
|
37
59.7%
|
| Week 36; n=46, 48, 50, 41 |
40
66.7%
|
43
71.7%
|
48
78.7%
|
36
58.1%
|
| Week 40; n=38, 35, 45, 39 |
33
55%
|
30
50%
|
41
67.2%
|
34
54.8%
|
| Week 48; n=33, 37, 45, 35 |
32
53.3%
|
33
55%
|
41
67.2%
|
33
53.2%
|
| Week 60; n=38, 38, 40, 37 |
37
61.7%
|
35
58.3%
|
37
60.7%
|
35
56.5%
|
| Week 72; n=35, 37, 44, 32 |
32
53.3%
|
35
58.3%
|
41
67.2%
|
27
43.5%
|
| Week 84; n=36, 39, 42, 33 |
34
56.7%
|
36
60%
|
39
63.9%
|
29
46.8%
|
| Week 96; n=31, 36, 33, 0 |
25
41.7%
|
32
53.3%
|
30
49.2%
|
|
| Week 108; n=23, 23, 29, 0 |
21
35%
|
20
33.3%
|
27
44.3%
|
|
| Week 120; n=30, 38, 41, 0 |
28
46.7%
|
36
60%
|
39
63.9%
|
|
| Week 132; n=29, 32, 40, 0 |
28
46.7%
|
30
50%
|
35
57.4%
|
|
| Week 144; n=33, 34, 43, 0 |
32
53.3%
|
29
48.3%
|
41
67.2%
|
|
| Week 156; n=31, 28, 39, 0 |
30
50%
|
25
41.7%
|
35
57.4%
|
|
| Week 168; n=29, 33, 41, 0 |
29
48.3%
|
24
40%
|
35
57.4%
|
|
| Week 180; n=26, 29, 39, 0 |
24
40%
|
24
40%
|
34
55.7%
|
|
| Week 192; n=30, 30, 39, 0 |
28
46.7%
|
27
45%
|
35
57.4%
|
|
| Week 204; n=29, 32, 38, 0 |
27
45%
|
26
43.3%
|
33
54.1%
|
|
| Week 216; n=29, 30, 37, 0 |
29
48.3%
|
27
45%
|
31
50.8%
|
|
| Week 228; n=27, 34, 40, 0 |
25
41.7%
|
28
46.7%
|
35
57.4%
|
|
| Week 240; n=28, 26, 41, 0 |
28
46.7%
|
22
36.7%
|
35
57.4%
|
|
| Week 252; n=23, 26, 33, 0 |
18
30%
|
21
35%
|
29
47.5%
|
|
| Week 264; n=15, 18, 24, 0 |
12
20%
|
16
26.7%
|
21
34.4%
|
|
| Week 276; n=14, 14, 21, 0 |
13
21.7%
|
13
21.7%
|
18
29.5%
|
|
| Week 288; n=12, 14, 18, 0 |
12
20%
|
10
16.7%
|
17
27.9%
|
|
| Week 300; n=12, 13, 20, 0 |
11
18.3%
|
7
11.7%
|
18
29.5%
|
|
| Week 312; n=1, 1, 0, 0 |
1
1.7%
|
1
1.7%
|
| Title | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase |
|---|---|
| Description | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. |
| Time Frame | Week 16 and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Week 16 |
90
150%
|
83
138.3%
|
87
142.6%
|
74
119.4%
|
| Week 24 |
87
145%
|
85
141.7%
|
87
142.6%
|
74
119.4%
|
| Title | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase |
|---|---|
| Description | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study. |
| Time Frame | Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-ME Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 52 | 53 | 55 | 47 |
| Week 24 |
96
160%
|
94
156.7%
|
96
157.4%
|
96
154.8%
|
| Week 26 |
90
150%
|
85
141.7%
|
95
155.7%
|
87
140.3%
|
| Week 28 |
98
163.3%
|
89
148.3%
|
95
155.7%
|
91
146.8%
|
| Week 32 |
96
160%
|
91
151.7%
|
96
157.4%
|
91
146.8%
|
| Week 36 |
98
163.3%
|
92
153.3%
|
95
155.7%
|
94
151.6%
|
| Week 40 |
96
160%
|
92
153.3%
|
95
155.7%
|
89
143.5%
|
| Week 48 |
92
153.3%
|
91
151.7%
|
96
157.4%
|
94
151.6%
|
| Week 60 |
90
150%
|
83
138.3%
|
95
155.7%
|
89
143.5%
|
| Week 72 |
83
138.3%
|
83
138.3%
|
95
155.7%
|
89
143.5%
|
| Week 84 |
83
138.3%
|
85
141.7%
|
95
155.7%
|
89
143.5%
|
| Week 96 |
79
131.7%
|
85
141.7%
|
93
152.5%
|
83
133.9%
|
| Title | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product. |
| Time Frame | Week 24 to Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Maintenance Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 52 | 53 | 55 | 47 |
| Any AE |
40
66.7%
|
50
83.3%
|
50
82%
|
35
56.5%
|
| Any SAE |
5
8.3%
|
5
8.3%
|
5
8.2%
|
2
3.2%
|
| Title | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase |
|---|---|
| Description | Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Time Frame | Week 24 to Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Maintenance Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 52 | 53 | 55 | 47 |
| ALT; Grade 1 |
9
15%
|
12
20%
|
17
27.9%
|
6
9.7%
|
| ALT; Grade 2 |
6
10%
|
6
10%
|
5
8.2%
|
3
4.8%
|
| ALT; Grade 3 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| ALT; Grade 4 |
1
1.7%
|
1
1.7%
|
0
0%
|
1
1.6%
|
| Albumin; Grade 1 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Albumin; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Albumin; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Albumin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| ALP; Grade 1 |
2
3.3%
|
1
1.7%
|
4
6.6%
|
4
6.5%
|
| ALP; Grade 2 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| ALP; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| ALP; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| AST; Grade 1 |
5
8.3%
|
13
21.7%
|
13
21.3%
|
5
8.1%
|
| AST; Grade 2 |
5
8.3%
|
8
13.3%
|
5
8.2%
|
2
3.2%
|
| AST; Grade 3 |
2
3.3%
|
0
0%
|
2
3.3%
|
3
4.8%
|
| AST; Grade 4 |
2
3.3%
|
1
1.7%
|
0
0%
|
2
3.2%
|
| CO2/bicarbonate; Grade 1 |
6
10%
|
14
23.3%
|
9
14.8%
|
8
12.9%
|
| CO2/bicarbonate; Grade 2 |
1
1.7%
|
0
0%
|
0
0%
|
1
1.6%
|
| CO2/bicarbonate; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CO2/bicarbonate; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Cholesterol; Grade 1 |
17
28.3%
|
17
28.3%
|
19
31.1%
|
9
14.5%
|
| Cholesterol; Grade 2 |
6
10%
|
12
20%
|
15
24.6%
|
10
16.1%
|
| Cholesterol; Grade 3 |
3
5%
|
0
0%
|
3
4.9%
|
4
6.5%
|
| Cholesterol; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CK; Grade 1 |
8
13.3%
|
9
15%
|
11
18%
|
5
8.1%
|
| CK; Grade 2 |
2
3.3%
|
4
6.7%
|
4
6.6%
|
0
0%
|
| CK; Grade 3 |
3
5%
|
2
3.3%
|
4
6.6%
|
3
4.8%
|
| CK; Grade 4 |
6
10%
|
6
10%
|
5
8.2%
|
5
8.1%
|
| Creatinine; Grade 1 |
1
1.7%
|
1
1.7%
|
2
3.3%
|
1
1.6%
|
| Creatinine; Grade 2 |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
| Creatinine; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Creatinine; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Glucose; Grade 1 |
17
28.3%
|
17
28.3%
|
20
32.8%
|
11
17.7%
|
| Glucose; Grade 2 |
14
23.3%
|
10
16.7%
|
11
18%
|
5
8.1%
|
| Glucose; Grade 3 |
0
0%
|
0
0%
|
2
3.3%
|
0
0%
|
| Glucose; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| LDL cholesterol; Grade 1 |
14
23.3%
|
16
26.7%
|
13
21.3%
|
8
12.9%
|
| LDL cholesterol; Grade 2 |
6
10%
|
11
18.3%
|
14
23%
|
6
9.7%
|
| LDL cholesterol; Grade 3 |
4
6.7%
|
2
3.3%
|
7
11.5%
|
4
6.5%
|
| LDL cholesterol; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lipase; Grade 1 |
9
15%
|
9
15%
|
8
13.1%
|
9
14.5%
|
| Lipase; Grade 2 |
9
15%
|
8
13.3%
|
11
18%
|
7
11.3%
|
| Lipase; Grade 3 |
5
8.3%
|
1
1.7%
|
6
9.8%
|
0
0%
|
| Lipase; Grade 4 |
2
3.3%
|
0
0%
|
2
3.3%
|
0
0%
|
| Inorganic phosphorus; Grade 1 |
5
8.3%
|
3
5%
|
9
14.8%
|
7
11.3%
|
| Inorganic phosphorus; Grade 2 |
10
16.7%
|
11
18.3%
|
5
8.2%
|
9
14.5%
|
| Inorganic phosphorus; Grade 3 |
2
3.3%
|
1
1.7%
|
5
8.2%
|
2
3.2%
|
| Inorganic phosphorus; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium; Grade 1 |
12
20%
|
7
11.7%
|
8
13.1%
|
4
6.5%
|
| Potassium; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| Potassium; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sodium; Grade 1 |
14
23.3%
|
12
20%
|
16
26.2%
|
7
11.3%
|
| Sodium; Grade 2 |
2
3.3%
|
1
1.7%
|
0
0%
|
1
1.6%
|
| Sodium; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sodium; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Total bilirubin; Grade 1 |
7
11.7%
|
1
1.7%
|
8
13.1%
|
0
0%
|
| Total bilirubin; Grade 2 |
2
3.3%
|
3
5%
|
4
6.6%
|
0
0%
|
| Total bilirubin; Grade 3 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Total bilirubin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Triglycerides; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Triglycerides; Grade 2 |
1
1.7%
|
4
6.7%
|
3
4.9%
|
1
1.6%
|
| Triglycerides; Grade 3 |
1
1.7%
|
0
0%
|
3
4.9%
|
1
1.6%
|
| Triglycerides; Grade 4 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| Title | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase |
|---|---|
| Description | Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Time Frame | Week 24 to Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Maintenance Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 52 | 53 | 55 | 47 |
| APTT; Grade 1 |
5
8.3%
|
5
8.3%
|
5
8.2%
|
5
8.1%
|
| APTT; Grade 2 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| APTT; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| APTT; Grade 4 |
1
1.7%
|
1
1.7%
|
1
1.6%
|
1
1.6%
|
| Hemoglobin; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 2 |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| INR; Grade 1 |
2
3.3%
|
4
6.7%
|
0
0%
|
3
4.8%
|
| INR; Grade 2 |
0
0%
|
1
1.7%
|
1
1.6%
|
1
1.6%
|
| INR; Grade 3 |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
| INR; Grade 4 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Platelet count; Grade 1 |
4
6.7%
|
0
0%
|
4
6.6%
|
1
1.6%
|
| Platelet count; Grade 2 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| Platelet count; Grade 3 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| Platelet count; Grade 4 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| PT; Grade 1 |
1
1.7%
|
3
5%
|
0
0%
|
3
4.8%
|
| PT; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| PT; Grade 3 |
0
0%
|
1
1.7%
|
1
1.6%
|
0
0%
|
| PT; Grade 4 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Total neutrophils; Grade 1 |
7
11.7%
|
9
15%
|
10
16.4%
|
2
3.2%
|
| Total neutrophils; Grade 2 |
5
8.3%
|
2
3.3%
|
3
4.9%
|
3
4.8%
|
| Total neutrophils; Grade 3 |
1
1.7%
|
0
0%
|
1
1.6%
|
1
1.6%
|
| Total neutrophils; Grade 4 |
1
1.7%
|
1
1.7%
|
3
4.9%
|
1
1.6%
|
| WBC count; Grade 1 |
2
3.3%
|
5
8.3%
|
2
3.3%
|
3
4.8%
|
| WBC count; Grade 2 |
1
1.7%
|
1
1.7%
|
1
1.6%
|
0
0%
|
| WBC count; Grade 3 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| WBC count; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With AEs and SAEs Over Time |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product. |
| Time Frame | Up to Week 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Any AE |
57
95%
|
57
95%
|
60
98.4%
|
60
96.8%
|
| Any SAE |
13
21.7%
|
12
20%
|
11
18%
|
4
6.5%
|
| Title | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time |
|---|---|
| Description | Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Time Frame | Up to Week 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| ALT; Grade 1 |
9
15%
|
12
20%
|
19
31.1%
|
8
12.9%
|
| ALT; Grade 2 |
6
10%
|
6
10%
|
5
8.2%
|
4
6.5%
|
| ALT; Grade 3 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| ALT; Grade 4 |
1
1.7%
|
1
1.7%
|
2
3.3%
|
1
1.6%
|
| Albumin; Grade 1 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Albumin; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Albumin; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Albumin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| ALP; Grade 1 |
2
3.3%
|
1
1.7%
|
4
6.6%
|
5
8.1%
|
| ALP; Grade 2 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| ALP; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| ALP; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| AST; Grade 1 |
7
11.7%
|
13
21.7%
|
15
24.6%
|
7
11.3%
|
| AST; Grade 2 |
6
10%
|
8
13.3%
|
5
8.2%
|
2
3.2%
|
| AST; Grade 3 |
2
3.3%
|
0
0%
|
4
6.6%
|
3
4.8%
|
| AST; Grade 4 |
2
3.3%
|
1
1.7%
|
0
0%
|
2
3.2%
|
| CO2/bicarbonate; Grade 1 |
6
10%
|
14
23.3%
|
9
14.8%
|
8
12.9%
|
| CO2/bicarbonate; Grade 2 |
1
1.7%
|
0
0%
|
0
0%
|
1
1.6%
|
| CO2/bicarbonate; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CO2/bicarbonate; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Cholesterol; Grade 1 |
17
28.3%
|
17
28.3%
|
19
31.1%
|
9
14.5%
|
| Cholesterol; Grade 2 |
7
11.7%
|
12
20%
|
15
24.6%
|
10
16.1%
|
| Cholesterol; Grade 3 |
3
5%
|
0
0%
|
3
4.9%
|
6
9.7%
|
| Cholesterol; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CK; Grade 1 |
9
15%
|
10
16.7%
|
12
19.7%
|
5
8.1%
|
| CK; Grade 2 |
2
3.3%
|
4
6.7%
|
4
6.6%
|
0
0%
|
| CK; Grade 3 |
3
5%
|
2
3.3%
|
4
6.6%
|
4
6.5%
|
| CK; Grade 4 |
7
11.7%
|
6
10%
|
5
8.2%
|
5
8.1%
|
| Creatinine; Grade 1 |
1
1.7%
|
1
1.7%
|
2
3.3%
|
1
1.6%
|
| Creatinine; Grade 2 |
1
1.7%
|
0
0%
|
0
0%
|
1
1.6%
|
| Creatinine; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Creatinine; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Glucose; Grade 1 |
19
31.7%
|
18
30%
|
21
34.4%
|
12
19.4%
|
| Glucose; Grade 2 |
14
23.3%
|
10
16.7%
|
11
18%
|
6
9.7%
|
| Glucose; Grade 3 |
0
0%
|
0
0%
|
2
3.3%
|
0
0%
|
| Glucose; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| LDL cholesterol; Grade 1 |
14
23.3%
|
17
28.3%
|
13
21.3%
|
8
12.9%
|
| LDL cholesterol; Grade 2 |
7
11.7%
|
11
18.3%
|
14
23%
|
7
11.3%
|
| LDL cholesterol; Grade 3 |
4
6.7%
|
2
3.3%
|
7
11.5%
|
4
6.5%
|
| LDL cholesterol; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lipase; Grade 1 |
11
18.3%
|
9
15%
|
9
14.8%
|
10
16.1%
|
| Lipase; Grade 2 |
9
15%
|
8
13.3%
|
11
18%
|
7
11.3%
|
| Lipase; Grade 3 |
5
8.3%
|
2
3.3%
|
6
9.8%
|
1
1.6%
|
| Lipase; Grade 4 |
2
3.3%
|
0
0%
|
2
3.3%
|
0
0%
|
| Inorganic phosphorus; Grade 1 |
5
8.3%
|
3
5%
|
10
16.4%
|
8
12.9%
|
| Inorganic phosphorus; Grade 2 |
11
18.3%
|
11
18.3%
|
6
9.8%
|
9
14.5%
|
| Inorganic phosphorus; Grade 3 |
2
3.3%
|
1
1.7%
|
5
8.2%
|
2
3.2%
|
| Inorganic phosphorus; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium; Grade 1 |
14
23.3%
|
7
11.7%
|
8
13.1%
|
4
6.5%
|
| Potassium; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| Potassium; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sodium; Grade 1 |
14
23.3%
|
12
20%
|
16
26.2%
|
11
17.7%
|
| Sodium; Grade 2 |
2
3.3%
|
1
1.7%
|
0
0%
|
1
1.6%
|
| Sodium; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sodium; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Total bilirubin; Grade 1 |
7
11.7%
|
1
1.7%
|
8
13.1%
|
0
0%
|
| Total bilirubin; Grade 2 |
2
3.3%
|
3
5%
|
4
6.6%
|
0
0%
|
| Total bilirubin; Grade 3 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Total bilirubin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Triglycerides; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Triglycerides; Grade 2 |
1
1.7%
|
4
6.7%
|
3
4.9%
|
1
1.6%
|
| Triglycerides; Grade 3 |
1
1.7%
|
0
0%
|
3
4.9%
|
1
1.6%
|
| Triglycerides; Grade 4 |
0
0%
|
0
0%
|
1
1.6%
|
1
1.6%
|
| Title | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time |
|---|---|
| Description | Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Time Frame | Up to Week 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| APTT; Grade 1 |
5
8.3%
|
5
8.3%
|
5
8.2%
|
5
8.1%
|
| APTT; Grade 2 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| APTT; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| APTT; Grade 4 |
1
1.7%
|
1
1.7%
|
1
1.6%
|
1
1.6%
|
| Hemoglobin; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 2 |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| INR; Grade 1 |
2
3.3%
|
4
6.7%
|
0
0%
|
3
4.8%
|
| INR; Grade 2 |
0
0%
|
1
1.7%
|
1
1.6%
|
1
1.6%
|
| INR; Grade 3 |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
| INR; Grade 4 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Platelet count; Grade 1 |
4
6.7%
|
0
0%
|
4
6.6%
|
1
1.6%
|
| Platelet count; Grade 2 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| Platelet count; Grade 3 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| Platelet count; Grade 4 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| PT; Grade 1 |
1
1.7%
|
3
5%
|
0
0%
|
3
4.8%
|
| PT; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| PT; Grade 3 |
0
0%
|
1
1.7%
|
1
1.6%
|
0
0%
|
| PT; Grade 4 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Total neutrophils; Grade 1 |
7
11.7%
|
9
15%
|
10
16.4%
|
2
3.2%
|
| Total neutrophils; Grade 2 |
5
8.3%
|
2
3.3%
|
3
4.9%
|
3
4.8%
|
| Total neutrophils; Grade 3 |
1
1.7%
|
0
0%
|
1
1.6%
|
1
1.6%
|
| Total neutrophils; Grade 4 |
1
1.7%
|
1
1.7%
|
3
4.9%
|
1
1.6%
|
| WBC count; Grade 1 |
2
3.3%
|
5
8.3%
|
2
3.3%
|
3
4.8%
|
| WBC count; Grade 2 |
1
1.7%
|
1
1.7%
|
1
1.6%
|
0
0%
|
| WBC count; Grade 3 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| WBC count; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 |
|---|---|
| Description | Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. |
| Time Frame | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| ALT; Baseline; n=60, 60, 61, 62 |
23.9
(12.38)
|
28.1
(17.65)
|
28.5
(20.60)
|
30.5
(29.21)
|
| ALT; Week 2; n=58, 56, 58, 58 |
24.0
(13.29)
|
26.3
(17.81)
|
27.2
(14.49)
|
30.0
(26.73)
|
| ALT; Week 4; n=58, 57, 59, 57 |
23.1
(14.31)
|
25.6
(17.29)
|
30.3
(24.25)
|
31.4
(27.43)
|
| ALT; Week 8; n=58, 55, 57, 54 |
25.4
(16.06)
|
29.3
(23.15)
|
35.9
(63.11)
|
25.0
(13.21)
|
| ALT; Week 12; n=58, 53, 57, 51 |
25.0
(15.37)
|
31.4
(28.65)
|
26.6
(16.27)
|
25.7
(17.44)
|
| ALT; Week 16; n=57, 54, 57, 52 |
26.0
(25.88)
|
28.5
(27.79)
|
26.9
(18.68)
|
30.4
(22.55)
|
| ALT; Week 20; n=56, 54, 55, 49 |
22.3
(11.62)
|
24.9
(15.72)
|
30.3
(24.34)
|
27.0
(15.71)
|
| ALT; Week 24; n=56, 53, 56, 47 |
20.9
(9.86)
|
27.5
(23.90)
|
28.6
(19.62)
|
25.7
(13.31)
|
| ALT; Week 26; n=48, 50, 53, 45 |
24.2
(16.54)
|
26.6
(26.63)
|
23.5
(10.77)
|
28.3
(25.23)
|
| ALT; Week 28; n=51, 52, 52, 45 |
20.4
(11.47)
|
26.5
(26.66)
|
24.8
(14.94)
|
24.2
(13.67)
|
| ALT; Week 32; n=52, 53, 55, 45 |
19.5
(9.83)
|
26.9
(27.66)
|
23.2
(14.67)
|
23.1
(10.19)
|
| ALT; Week 36; n=52, 52, 55, 45 |
23.4
(26.79)
|
24.7
(17.44)
|
24.2
(15.60)
|
23.5
(10.53)
|
| ALT; Week 40; n=52, 53, 55, 44 |
22.7
(18.13)
|
24.6
(15.43)
|
25.8
(23.50)
|
23.4
(10.92)
|
| ALT; Week 48; n=51, 53, 54, 44 |
18.4
(8.32)
|
24.8
(15.91)
|
24.8
(19.60)
|
22.6
(10.92)
|
| ALT; Week 60; n=48, 47, 53, 44 |
21.4
(17.70)
|
25.9
(16.69)
|
28.1
(26.70)
|
24.9
(13.59)
|
| ALT; Week 72; n=47, 47, 52, 42 |
19.9
(9.98)
|
30.7
(28.68)
|
26.3
(20.29)
|
22.7
(9.62)
|
| ALT; Week 84; n=46, 48, 52, 42 |
20.1
(11.56)
|
29.9
(20.77)
|
25.3
(19.53)
|
27.1
(32.55)
|
| ALT; Week 96; n=45, 48, 52, 40 |
22.0
(18.20)
|
48.7
(153.96)
|
25.5
(21.23)
|
24.3
(22.84)
|
| AST; Baseline; n=60, 60, 61, 62 |
25.0
(7.36)
|
27.5
(11.15)
|
28.1
(12.01)
|
31.5
(28.43)
|
| AST; Week 2; n=58, 56, 58, 58 |
25.6
(8.36)
|
26.6
(11.38)
|
26.8
(8.60)
|
32.8
(51.17)
|
| AST; Week 4; n=58, 57, 59, 57 |
24.0
(7.95)
|
25.0
(11.37)
|
28.3
(16.29)
|
29.0
(15.61)
|
| AST; Week 8; n=58, 55, 57, 54 |
28.7
(31.34)
|
29.5
(23.47)
|
32.8
(37.43)
|
24.4
(5.73)
|
| AST; Week 12; n=58, 53, 57, 51 |
26.3
(13.40)
|
29.0
(24.56)
|
25.5
(8.05)
|
24.4
(9.49)
|
| AST; Week 16; n=57, 54, 57, 52 |
24.2
(12.70)
|
29.2
(24.00)
|
26.5
(9.42)
|
36.7
(71.83)
|
| AST; Week 20; n=56, 54, 55, 49 |
26.0
(20.71)
|
24.2
(10.38)
|
31.7
(26.31)
|
28.7
(28.75)
|
| AST; Week 24; n=56, 53, 56, 47 |
23.3
(8.93)
|
27.2
(17.43)
|
28.6
(14.12)
|
26.1
(9.61)
|
| AST; Week 26; n=48, 50, 53, 45 |
28.4
(28.28)
|
26.9
(18.86)
|
24.5
(6.64)
|
25.8
(12.21)
|
| AST; Week 28; n=51, 52, 52, 45 |
22.6
(8.77)
|
26.7
(16.58)
|
25.5
(11.24)
|
23.7
(7.89)
|
| AST; Week 32; n=52, 53, 55, 45 |
21.9
(7.74)
|
26.5
(19.14)
|
25.6
(9.19)
|
25.4
(12.33)
|
| AST; Week 36; n=52, 52, 55, 45 |
29.2
(39.15)
|
25.4
(12.50)
|
26.4
(11.38)
|
26.3
(13.66)
|
| AST; Week 40; n=52, 53, 55, 44 |
24.7
(14.04)
|
24.5
(10.35)
|
26.5
(14.21)
|
23.0
(6.17)
|
| AST; Week 48; n=51, 53, 54, 44 |
21.4
(8.02)
|
24.3
(12.32)
|
24.2
(9.26)
|
23.7
(8.45)
|
| AST; Week 60; n=48, 47, 53, 44 |
23.4
(10.41)
|
25.3
(12.77)
|
30.4
(21.00)
|
24.9
(8.31)
|
| AST; Week 72; n=47, 47, 52, 42 |
21.8
(7.67)
|
31.0
(22.80)
|
26.4
(10.52)
|
22.9
(6.28)
|
| AST; Week 84; n=46, 48, 52, 42 |
22.3
(8.10)
|
29.2
(16.93)
|
25.2
(9.11)
|
29.9
(37.33)
|
| AST; Week 96; n=45, 48, 52, 40 |
23.6
(22.38)
|
47.7
(150.51)
|
25.9
(12.90)
|
27.7
(35.71)
|
| CK; Baseline; n=60, 60, 61, 62 |
197.3
(178.83)
|
295.9
(604.02)
|
181.2
(217.99)
|
349.8
(1521.09)
|
| CK; Week 2; n=58, 56, 58, 58 |
237.9
(271.07)
|
276.1
(468.74)
|
184.8
(143.83)
|
512.1
(2788.37)
|
| CK; Week 4; n=58, 57, 59, 57 |
196.7
(159.74)
|
221.8
(426.95)
|
180.5
(174.80)
|
236.2
(563.36)
|
| CK; Week 8; n=58, 55, 57, 54 |
413.3
(1523.18)
|
427.2
(1518.27)
|
451.7
(1788.60)
|
152.9
(94.19)
|
| CK; Week 12; n=58, 53, 57, 51 |
316.1
(570.21)
|
314.7
(1116.09)
|
211.8
(174.07)
|
161.2
(163.26)
|
| CK; Week 16; n=57, 54, 57, 52 |
195.1
(180.51)
|
427.3
(1339.99)
|
213.3
(190.94)
|
646.5
(3471.23)
|
| CK; Week 20; n=56, 54, 55, 49 |
342.7
(953.66)
|
202.1
(309.41)
|
485.3
(1835.11)
|
528.2
(2643.29)
|
| CK; Week 24; n=56, 53, 56, 47 |
226.0
(230.13)
|
306.3
(690.18)
|
243.0
(228.95)
|
247.4
(498.72)
|
| CK; Week 26; n=48, 50, 53, 45 |
344.1
(606.10)
|
267.7
(516.53)
|
242.5
(275.72)
|
163.5
(156.79)
|
| CK; Week 28; n=51, 52, 52, 45 |
213.4
(182.12)
|
276.8
(581.44)
|
290.4
(457.59)
|
154.7
(168.77)
|
| CK; Week 32; n=52, 53, 55, 45 |
205.6
(171.74)
|
248.8
(525.79)
|
311.3
(437.31)
|
254.7
(778.33)
|
| CK; Week 36; n=52, 52, 55, 45 |
528.4
(1984.77)
|
242.9
(353.65)
|
255.2
(275.74)
|
303.1
(615.91)
|
| CK; Week 40; n=52, 53, 55, 44 |
259.5
(381.33)
|
225.4
(342.50)
|
292.6
(360.32)
|
150.2
(96.11)
|
| CK; Week 48; n=51, 53, 54, 44 |
203.5
(136.48)
|
219.3
(527.75)
|
219.8
(195.62)
|
146.3
(88.07)
|
| CK; Week 60; n=48, 47, 53, 44 |
315.7
(730.27)
|
215.5
(340.37)
|
399.6
(923.74)
|
168.0
(154.36)
|
| CK; Week 72; n=47, 47, 52, 42 |
182.5
(148.31)
|
354.0
(911.76)
|
247.7
(348.72)
|
120.5
(59.89)
|
| CK; Week 84; n=46, 48, 52, 42 |
204.3
(160.30)
|
329.2
(724.97)
|
195.0
(164.14)
|
258.6
(650.38)
|
| CK; Week 96; n=45, 48, 52, 40 |
542.7
(2451.57)
|
272.8
(589.15)
|
199.7
(194.46)
|
281.1
(903.71)
|
| Title | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 |
|---|---|
| Description | Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Creatinine; Baseline; n=60, 60, 61, 62 |
80.4
(13.69)
|
80.5
(13.55)
|
79.9
(14.11)
|
83.1
(13.41)
|
| Creatinine; Week 2; n=58, 56, 58, 58 |
83.8
(14.33)
|
83.3
(14.10)
|
84.6
(15.27)
|
83.8
(15.29)
|
| Creatinine; Week 4; n=58, 57, 59, 57 |
82.9
(15.45)
|
83.0
(14.55)
|
84.2
(14.28)
|
83.1
(14.22)
|
| Creatinine; Week 8; n=58, 55, 57, 54 |
82.9
(13.79)
|
82.2
(13.03)
|
83.5
(14.41)
|
82.4
(13.94)
|
| Creatinine; Week 12; n=58, 53, 57, 51 |
83.8
(13.33)
|
82.7
(14.96)
|
84.1
(14.64)
|
81.1
(12.83)
|
| Creatinine; Week 16; n=57, 54, 57, 52 |
83.4
(17.07)
|
82.3
(14.56)
|
82.4
(14.16)
|
79.6
(11.83)
|
| Creatinine; Week 20; n=56, 54, 55, 49 |
83.2
(12.95)
|
82.0
(14.42)
|
86.1
(14.34)
|
79.5
(11.72)
|
| Creatinine; Week 24; n=56, 53, 56, 47 |
83.2
(13.07)
|
83.3
(15.56)
|
85.2
(13.93)
|
80.0
(20.74)
|
| Creatinine; Week 26; n=48, 50, 53, 45 |
83.4
(13.45)
|
82.6
(14.15)
|
87.0
(13.82)
|
78.6
(9.61)
|
| Creatinine; Week 28; n=51, 52, 52, 45 |
83.0
(13.32)
|
83.8
(14.84)
|
85.6
(13.96)
|
78.5
(10.34)
|
| Creatinine; Week 32; n=52, 53, 55, 45 |
83.8
(14.11)
|
82.6
(13.48)
|
85.7
(14.34)
|
78.1
(9.90)
|
| Creatinine; Week 36; n=52, 52, 55, 45 |
83.5
(12.68)
|
84.6
(13.22)
|
86.7
(16.21)
|
78.4
(10.87)
|
| Creatinine; Week 40; n=52, 53, 55, 44 |
83.3
(12.60)
|
83.2
(13.04)
|
85.4
(14.38)
|
79.2
(15.99)
|
| Creatinine; Week 48; n=51, 53, 54, 44 |
83.4
(13.48)
|
83.1
(14.55)
|
85.0
(14.54)
|
79.0
(12.52)
|
| Creatinine; Week 60; n=48, 47, 53, 44 |
83.9
(13.85)
|
83.0
(14.31)
|
85.2
(14.57)
|
77.9
(11.13)
|
| Creatinine; Week 72; n=47, 47, 52, 42 |
84.5
(12.46)
|
86.1
(14.95)
|
87.3
(14.95)
|
77.7
(11.44)
|
| Creatinine; Week 84; n=46, 48, 52, 42 |
85.0
(15.06)
|
84.8
(17.41)
|
87.3
(13.15)
|
79.7
(11.20)
|
| Creatinine; Week 96; n=45, 48, 52, 40 |
82.0
(11.46)
|
86.4
(17.24)
|
88.5
(14.75)
|
81.0
(10.10)
|
| T. Bilirubin; Baseline; n=60, 60, 61, 62 |
9.2
(4.65)
|
9.4
(4.59)
|
10.5
(5.48)
|
9.7
(4.42)
|
| T. Bilirubin; Week 2; n=58, 56, 58, 58 |
9.2
(4.48)
|
9.1
(4.50)
|
10.0
(5.92)
|
6.8
(1.71)
|
| T. Bilirubin; Week 4; n=58, 57, 59, 57 |
9.4
(4.40)
|
9.3
(4.47)
|
9.8
(6.05)
|
6.4
(1.61)
|
| T. Bilirubin; Week 8; n=58, 55, 57, 54 |
9.3
(4.50)
|
9.0
(3.33)
|
10.1
(5.55)
|
6.3
(1.46)
|
| T. Bilirubin; Week 12; n=58, 53, 57, 51 |
9.5
(5.16)
|
8.9
(3.79)
|
10.2
(5.47)
|
7.0
(2.57)
|
| T. Bilirubin; Week 16; n=57, 54, 57, 52 |
9.6
(5.04)
|
8.5
(3.90)
|
10.4
(4.88)
|
7.0
(2.61)
|
| T. Bilirubin; Week 20; n=56, 54, 55, 49 |
9.0
(4.09)
|
9.0
(4.91)
|
10.4
(5.49)
|
6.8
(1.67)
|
| T. Bilirubin; Week 24; n=56, 53, 56, 47 |
9.6
(5.18)
|
9.8
(5.09)
|
10.0
(4.52)
|
6.6
(1.60)
|
| T. Bilirubin; Week 26; n=48, 50, 53, 45 |
10.6
(4.97)
|
9.9
(5.83)
|
12.0
(5.11)
|
6.8
(2.19)
|
| T. Bilirubin; Week 28; n=51, 52, 52, 45 |
10.3
(4.87)
|
10.2
(5.90)
|
11.4
(4.77)
|
6.4
(1.51)
|
| T. Bilirubin; Week 32; n=52, 53, 55, 45 |
9.8
(4.91)
|
9.8
(4.80)
|
11.7
(6.70)
|
6.6
(1.74)
|
| T. Bilirubin; Week 36; n=52, 52, 55, 45 |
10.3
(5.25)
|
10.1
(5.47)
|
12.2
(6.08)
|
6.5
(1.71)
|
| T. Bilirubin; Week 40; n=52, 53, 55, 44 |
10.8
(5.81)
|
11.2
(7.04)
|
12.3
(6.67)
|
6.3
(1.53)
|
| T. Bilirubin; Week 48; n=51, 53, 54, 44 |
10.0
(4.96)
|
9.6
(3.86)
|
10.4
(4.91)
|
6.6
(1.65)
|
| T. Bilirubin; Week 60; n=48, 47, 53, 44 |
11.2
(4.28)
|
9.8
(3.75)
|
11.6
(6.28)
|
7.0
(2.13)
|
| T. Bilirubin; Week 72; n=47, 47, 52, 42 |
10.8
(6.63)
|
10.0
(4.89)
|
11.4
(5.87)
|
6.5
(1.40)
|
| T. Bilirubin; Week 84; n=46, 48, 52, 42 |
11.7
(6.77)
|
9.9
(4.35)
|
12.0
(5.64)
|
6.6
(2.27)
|
| T. Bilirubin; Week 96; n=45, 48, 52, 40 |
10.3
(5.29)
|
9.9
(4.58)
|
12.5
(5.61)
|
6.8
(1.80)
|
| Title | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
|---|---|
| Description | Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Baseline; n=60, 60, 61, 62 |
131.0
(28.18)
|
135.2
(41.33)
|
128.3
(33.51)
|
125.6
(35.30)
|
| Week 2; n=1, 1, 0, 3 |
96.0
(NA)
|
106.0
(NA)
|
99.0
(31.00)
|
|
| Week 4; n=58, 57, 59, 57 |
129.3
(31.29)
|
132.5
(42.28)
|
122.4
(33.00)
|
127.0
(35.64)
|
| Week 8; n=2, 1, 1, 1 |
125.0
(35.36)
|
124.0
(NA)
|
143.0
(NA)
|
101.0
(NA)
|
| Week 16; n=55, 53, 56, 49 |
132.4
(50.97)
|
139.4
(42.30)
|
123.9
(31.85)
|
132.3
(39.97)
|
| Week 20; n=2, 0, 0, 1 |
137.0
(11.31)
|
122.0
(NA)
|
||
| Week 24; n=52, 53, 55, 46 |
127.9
(30.90)
|
132.8
(39.93)
|
120.7
(27.41)
|
135.1
(38.98)
|
| Week 26; n=0, 1, 0, 0 |
147.0
(NA)
|
|||
| Week 40; n=0, 1, 0, 0 |
180.0
(NA)
|
|||
| Week 48; n=51, 50, 54, 44 |
127.0
(30.01)
|
139.2
(42.07)
|
122.3
(29.21)
|
131.0
(44.41)
|
| Week 60; n=0, 0, 0, 1 |
144.0
(NA)
|
|||
| Week 96; n=45, 48, 52, 40 |
130.8
(40.80)
|
137.7
(45.07)
|
116.6
(27.05)
|
134.8
(43.35)
|
| Title | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 |
|---|---|
| Description | Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Baseline; n=60, 60, 61, 62 |
141.9
(12.46)
|
143.2
(10.66)
|
146.6
(13.41)
|
145.4
(12.39)
|
| Week 2; n=57, 56, 59, 59 |
142.0
(13.84)
|
142.8
(11.68)
|
145.9
(12.05)
|
146.4
(13.49)
|
| Week 4; n=57, 57, 59, 57 |
141.9
(13.39)
|
143.5
(11.69)
|
147.3
(12.13)
|
146.6
(13.06)
|
| Week 8; n=58, 56, 56, 55 |
144.9
(13.10)
|
147.7
(11.88)
|
148.6
(12.10)
|
148.1
(12.32)
|
| Week 12; n=58, 53, 57, 51 |
144.3
(12.19)
|
147.4
(10.60)
|
149.1
(11.25)
|
149.2
(13.14)
|
| Week 16; n=57, 54, 57, 52 |
143.5
(11.77)
|
146.5
(10.71)
|
148.7
(11.08)
|
147.6
(12.05)
|
| Week 20; n=56, 54, 55, 49 |
144.3
(13.33)
|
146.9
(11.23)
|
149.8
(11.11)
|
147.2
(12.18)
|
| Week 24; n=56, 53, 56, 47 |
144.8
(12.66)
|
147.8
(10.69)
|
150.4
(11.65)
|
148.5
(11.31)
|
| Week 26; n=48, 50, 53, 45 |
144.4
(13.30)
|
145.8
(11.63)
|
149.8
(11.47)
|
148.2
(12.32)
|
| Week 28; n=50, 52, 52, 45 |
143.7
(13.20)
|
146.8
(10.89)
|
149.3
(10.15)
|
145.9
(13.17)
|
| Week 32; n=51, 53, 55, 45 |
144.6
(9.53)
|
146.1
(10.44)
|
150.5
(11.19)
|
145.9
(11.41)
|
| Week 36; n=52, 53, 55, 44 |
142.3
(11.07)
|
145.9
(11.24)
|
149.8
(11.26)
|
145.0
(10.73)
|
| Week 40; n=51, 53, 55, 45 |
142.2
(11.06)
|
145.2
(11.03)
|
149.2
(11.71)
|
145.1
(9.98)
|
| Week 48; n=51, 53, 54, 44 |
142.9
(9.15)
|
145.7
(10.59)
|
146.5
(12.48)
|
145.4
(12.24)
|
| Week 60; n=48, 47, 52, 44 |
144.5
(9.91)
|
148.3
(10.96)
|
149.8
(10.82)
|
147.6
(12.73)
|
| Week 72; n=47, 48, 52, 42 |
143.9
(10.24)
|
148.1
(10.15)
|
149.6
(11.46)
|
147.7
(11.22)
|
| Week 84; n=46, 48, 51, 42 |
145.6
(11.00)
|
147.7
(10.04)
|
150.3
(10.38)
|
147.0
(11.77)
|
| Week 96; n=46, 46, 52, 41 |
144.9
(12.41)
|
147.1
(11.06)
|
150.8
(10.37)
|
147.0
(11.03)
|
| Title | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 |
|---|---|
| Description | Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed. |
| Time Frame | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| T. neutrophils; Baseline; n=60, 60, 61, 62 |
2.643
(1.1237)
|
2.891
(1.4383)
|
2.487
(1.0240)
|
2.441
(1.1548)
|
| T. neutrophils; Week 2; n=57, 56, 59, 59 |
2.723
(1.1402)
|
2.776
(1.0729)
|
2.598
(1.1295)
|
3.207
(1.6307)
|
| T. neutrophils; Week 4; n=57, 57, 59, 57 |
2.685
(1.2477)
|
2.771
(1.2587)
|
2.649
(1.0692)
|
2.848
(1.8642)
|
| T. neutrophils; Week 8; n=58, 56, 56, 55 |
2.899
(1.2111)
|
2.802
(1.1296)
|
2.738
(1.1533)
|
2.746
(0.9969)
|
| T. neutrophils; Week 12; n=58, 53, 57, 51 |
2.812
(1.1377)
|
2.933
(1.5977)
|
2.822
(1.3294)
|
2.979
(1.7673)
|
| T. neutrophils; Week 16; n=57, 54, 57, 52 |
3.078
(1.5948)
|
2.716
(1.1022)
|
2.665
(1.0287)
|
2.858
(1.1909)
|
| T. neutrophils; Week 20; n=56, 54, 55, 49 |
2.958
(1.2918)
|
2.904
(1.1794)
|
2.989
(1.6589)
|
3.187
(1.6424)
|
| T. neutrophils; Week 24; n=56, 53, 56, 47 |
3.151
(1.2378)
|
2.996
(1.5425)
|
2.884
(1.0047)
|
3.142
(1.6483)
|
| T. neutrophils; Week 26; n=48, 50, 53, 45 |
2.885
(1.0874)
|
2.958
(1.2097)
|
2.830
(1.0354)
|
2.886
(1.3159)
|
| T. neutrophils; Week 28; n=50, 52, 52, 45 |
3.183
(1.0674)
|
3.005
(1.0029)
|
2.989
(1.4078)
|
2.916
(1.0731)
|
| T. neutrophils; Week 32; n=51, 53, 55, 45 |
2.797
(0.9490)
|
3.036
(1.1931)
|
3.167
(1.3992)
|
3.174
(1.7150)
|
| T. neutrophils; Week 36; n=52, 53, 55, 44 |
3.162
(1.1538)
|
2.916
(1.2331)
|
3.010
(1.0698)
|
2.914
(1.2530)
|
| T. neutrophils; Week 40; n=51, 53, 55, 45 |
3.155
(1.3417)
|
3.065
(1.2945)
|
3.050
(1.0745)
|
3.187
(1.6006)
|
| T. neutrophils; Week 48; n=51, 53, 54, 44 |
3.138
(1.3751)
|
3.132
(1.1976)
|
3.004
(1.1720)
|
3.134
(1.6646)
|
| T. neutrophils; Week 60; n=48, 47, 52, 44 |
3.164
(1.3804)
|
3.333
(1.5642)
|
3.200
(1.2159)
|
3.269
(1.3866)
|
| T. neutrophils; Week 72; n=47, 48, 52, 42 |
3.197
(1.2931)
|
3.131
(1.2337)
|
3.163
(1.0874)
|
3.361
(1.8047)
|
| T. neutrophils; Week 84; n=46, 48, 51, 42 |
3.245
(1.4593)
|
3.385
(1.3591)
|
3.512
(1.3176)
|
3.259
(1.6532)
|
| T. neutrophils; Week 96; n=46, 46, 52, 41 |
3.466
(1.1229)
|
3.540
(1.7870)
|
3.494
(1.2790)
|
3.297
(1.4509)
|
| Platelet count; Baseline; n=60, 60, 61, 62 |
212.5
(53.22)
|
202.3
(51.74)
|
190.0
(55.71)
|
200.1
(52.36)
|
| Platelet count; Week 2; n=57, 56, 59, 59 |
225.0
(54.84)
|
222.0
(48.82)
|
204.8
(50.51)
|
216.2
(52.60)
|
| Platelet count; Week 4; n=57, 57, 59, 57 |
225.2
(52.94)
|
222.4
(52.61)
|
204.6
(57.51)
|
216.0
(55.41)
|
| Platelet count; Week 8; n=58, 56, 56, 55 |
224.5
(50.94)
|
228.4
(57.01)
|
211.5
(56.80)
|
209.8
(48.62)
|
| Platelet count; Week 12; n=58, 53, 57, 51 |
227.2
(49.64)
|
216.4
(52.46)
|
209.2
(51.62)
|
213.7
(50.65)
|
| Platelet count; Week 16; n=57, 54, 57, 52 |
230.0
(59.33)
|
212.4
(54.22)
|
209.5
(50.32)
|
211.4
(50.56)
|
| Platelet count; Week 20; n=56, 54, 55, 49 |
231.3
(55.14)
|
215.5
(47.03)
|
205.4
(48.40)
|
214.9
(51.41)
|
| Platelet count; Week 24; n=56, 53, 56, 47 |
226.1
(52.17)
|
219.7
(50.75)
|
210.9
(56.34)
|
220.9
(67.67)
|
| Platelet count; Week 26; n=48, 50, 53, 45 |
224.9
(56.06)
|
215.5
(53.10)
|
199.4
(60.65)
|
214.4
(53.90)
|
| Platelet count; Week 28; n=50, 52, 52, 45 |
223.3
(50.28)
|
217.0
(56.54)
|
209.8
(56.65)
|
215.4
(57.81)
|
| Platelet count; Week 32; n=51, 52, 55, 45 |
220.5
(55.37)
|
214.0
(46.66)
|
207.8
(53.33)
|
212.6
(52.27)
|
| Platelet count; Week 36; n=52, 53, 55, 44 |
220.0
(47.58)
|
212.1
(51.61)
|
204.2
(54.34)
|
209.8
(52.54)
|
| Platelet count; Week 40; n=51, 53, 54, 45 |
224.9
(52.93)
|
210.1
(55.87)
|
199.3
(52.37)
|
217.7
(54.40)
|
| Platelet count; Week 48; n=51, 52, 53, 44 |
225.6
(60.05)
|
221.2
(56.12)
|
209.9
(56.81)
|
220.3
(52.52)
|
| Platelet count; Week 60; n=48, 47, 51, 44 |
232.5
(57.00)
|
219.8
(55.01)
|
212.2
(53.68)
|
230.5
(56.39)
|
| Platelet count; Week 72; n=47, 48, 52, 42 |
234.0
(52.53)
|
224.4
(50.06)
|
212.2
(52.59)
|
225.9
(52.62)
|
| Platelet count; Week 84; n=46, 48, 51, 42 |
224.8
(52.36)
|
218.8
(49.15)
|
210.1
(51.72)
|
216.5
(53.09)
|
| Platelet count; Week 96; n=46, 45, 51, 41 |
237.1
(58.94)
|
221.8
(57.95)
|
210.6
(57.34)
|
214.0
(51.10)
|
| WBC count; Baseline; n=60, 60, 61, 62 |
5.06
(1.552)
|
5.19
(1.632)
|
4.72
(1.332)
|
4.70
(1.388)
|
| WBC count; Week 2; n=57, 56, 59, 59 |
5.32
(1.602)
|
5.30
(1.448)
|
5.02
(1.355)
|
5.45
(1.856)
|
| WBC count; Week 4; n=57, 57, 59, 57 |
5.24
(1.802)
|
5.17
(1.604)
|
5.02
(1.342)
|
5.02
(1.993)
|
| WBC count; Week 8; n=58, 56, 56, 55 |
5.44
(1.751)
|
5.30
(1.556)
|
5.04
(1.230)
|
5.02
(1.195)
|
| WBC count; Week 12; n=58, 53, 57, 51 |
5.41
(1.560)
|
5.50
(1.794)
|
5.34
(1.524)
|
5.27
(1.899)
|
| WBC count; Week 16; n=57, 54, 57, 52 |
5.56
(1.895)
|
5.20
(1.337)
|
4.97
(1.108)
|
5.13
(1.480)
|
| WBC count; Week 20; n=56, 54, 55, 49 |
5.46
(1.486)
|
5.41
(1.354)
|
5.39
(1.877)
|
5.50
(1.763)
|
| WBC count; Week 24; n=56, 53, 56, 47 |
5.57
(1.558)
|
5.53
(1.993)
|
5.28
(1.367)
|
5.34
(1.854)
|
| WBC count; Week 26; n=48, 50, 53, 45 |
5.30
(1.294)
|
5.50
(1.642)
|
5.29
(1.315)
|
5.08
(1.381)
|
| WBC count; Week 28; n=50, 52, 52, 45 |
5.71
(1.426)
|
5.53
(1.493)
|
5.38
(1.542)
|
5.14
(1.254)
|
| WBC count; Week 32; n=51, 53, 55, 45 |
5.30
(1.399)
|
5.63
(1.456)
|
5.57
(1.720)
|
5.48
(1.939)
|
| WBC count; Week 36; n=52, 53, 55, 44 |
5.64
(1.461)
|
5.48
(1.756)
|
5.56
(1.303)
|
5.17
(1.312)
|
| WBC count; Week 40; n=51, 53, 55, 45 |
5.63
(1.607)
|
5.61
(1.687)
|
5.45
(1.255)
|
5.51
(1.808)
|
| WBC count; Week 48; n=51, 53, 54, 44 |
5.51
(1.663)
|
5.72
(1.695)
|
5.41
(1.314)
|
5.53
(1.818)
|
| WBC count; Week 60; n=48, 47, 52, 44 |
5.73
(1.749)
|
5.93
(1.677)
|
5.63
(1.491)
|
5.75
(1.608)
|
| WBC count; Week 72; n=47, 48, 52, 42 |
5.80
(1.671)
|
5.71
(1.550)
|
5.73
(1.297)
|
5.84
(2.104)
|
| WBC count; Week 84; n=46, 48, 51, 42 |
5.91
(1.845)
|
6.11
(1.718)
|
6.05
(1.469)
|
5.78
(1.658)
|
| WBC count; Week 96; n=46, 46, 52, 41 |
6.14
(1.622)
|
6.15
(1.933)
|
6.01
(1.489)
|
5.75
(1.556)
|
| Title | Change From Baseline in ALT, AST and CK Over Time by Visit |
|---|---|
| Description | Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Time Frame | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| ALT; Week 2; n=58, 56, 58, 58 |
0.1
(7.47)
|
-2.1
(12.74)
|
-1.5
(14.75)
|
-1.3
(23.63)
|
| ALT; Week 4; n=58, 57, 59, 57 |
-0.7
(8.94)
|
-2.6
(12.13)
|
1.7
(22.01)
|
0.1
(29.43)
|
| ALT; Week 8; n=58, 55, 57, 54 |
2.2
(10.71)
|
0.5
(18.49)
|
8.0
(56.59)
|
-6.3
(29.64)
|
| ALT; Week 12; n=58, 53, 57, 51 |
1.2
(8.91)
|
2.7
(24.70)
|
-0.6
(13.40)
|
-6.3
(33.57)
|
| ALT; Week 16; n=57, 54, 57, 52 |
2.1
(19.92)
|
0.1
(27.07)
|
-0.3
(13.36)
|
-1.6
(38.90)
|
| ALT; Week 20; n=56, 54, 55, 49 |
-0.7
(8.58)
|
-3.6
(14.07)
|
3.0
(18.56)
|
-4.8
(34.09)
|
| ALT; Week 24; n=56, 53, 56, 47 |
-2.1
(7.93)
|
-1.2
(20.79)
|
1.4
(19.49)
|
-6.0
(33.13)
|
| ALT; Week 26; n=48, 50, 53, 45 |
1.1
(16.32)
|
-2.6
(24.31)
|
-1.7
(13.07)
|
-3.7
(41.02)
|
| ALT; Week 28; n=51, 52, 52, 45 |
-2.3
(7.87)
|
-2.3
(25.40)
|
-2.9
(17.79)
|
-8.1
(33.92)
|
| ALT; Week 32; n=52, 53, 55, 45 |
-3.1
(8.55)
|
-1.7
(25.75)
|
-4.0
(13.90)
|
-8.6
(34.85)
|
| ALT; Week 36; n=52, 52, 55, 45 |
0.8
(23.68)
|
-4.2
(17.84)
|
-3.0
(15.31)
|
-8.2
(32.34)
|
| ALT; Week 40; n=52, 53, 55, 44 |
0.1
(15.48)
|
-4.1
(15.85)
|
-1.4
(15.96)
|
-8.0
(32.36)
|
| ALT; Week 48; n=51, 53, 54, 44 |
-4.1
(9.03)
|
-3.8
(17.77)
|
-2.4
(14.60)
|
-8.6
(34.80)
|
| ALT; Week 60; n=48, 47, 53, 44 |
-1.0
(15.72)
|
-2.6
(17.74)
|
0.5
(18.13)
|
-6.3
(36.82)
|
| ALT; Week 72; n=47, 47, 52, 42 |
-2.8
(9.92)
|
2.7
(30.95)
|
-0.9
(15.27)
|
-8.5
(36.32)
|
| ALT; Week 84; n=46, 48, 52, 42 |
-2.4
(10.87)
|
1.9
(22.60)
|
-2.0
(16.90)
|
-4.0
(49.06)
|
| ALT; Week 96; n=45, 48, 52, 40 |
-0.4
(18.47)
|
20.6
(154.71)
|
-1.7
(17.12)
|
-7.6
(20.22)
|
| ALT; Week 108; n=43, 46, 48, 0 |
0.5
(11.41)
|
-2.7
(20.04)
|
-0.7
(20.63)
|
|
| ALT; Week 120; n=40, 45, 48, 0 |
4.4
(23.14)
|
-2.6
(18.42)
|
-3.7
(15.82)
|
|
| ALT; Week 132; n=40, 46, 49, 0 |
4.3
(23.58)
|
-3.0
(20.18)
|
-3.8
(17.80)
|
|
| ALT; Week 144; n=37, 45, 47, 0 |
0.1
(13.01)
|
-3.4
(17.81)
|
-1.8
(15.40)
|
|
| ALT; Week 156; n=37, 42, 49, 0 |
-0.5
(13.86)
|
-1.8
(19.51)
|
-2.2
(27.94)
|
|
| ALT; Week 168; n=35, 43, 47, 0 |
2.3
(11.40)
|
-1.1
(19.14)
|
-3.6
(24.29)
|
|
| ALT; Week 180; n=36, 41, 47, 0 |
1.7
(12.96)
|
-2.8
(15.68)
|
-1.2
(31.69)
|
|
| ALT; Week 192; n=36, 39, 47, 0 |
4.9
(17.56)
|
-3.3
(16.07)
|
1.3
(35.53)
|
|
| ALT; Week 204; n=34, 39, 47, 0 |
1.9
(11.42)
|
-1.7
(16.25)
|
-3.4
(24.00)
|
|
| ALT; Week 216; n=33, 39, 46, 0 |
1.7
(11.28)
|
-3.0
(13.37)
|
-2.7
(26.90)
|
|
| ALT; Week 228; n=32, 39, 47, 0 |
36.8
(162.51)
|
-1.1
(13.68)
|
0.5
(17.72)
|
|
| ALT; Week 240; n=30, 39, 46, 0 |
5.3
(38.37)
|
-0.1
(16.56)
|
-0.7
(18.20)
|
|
| ALT; Week 252; n=31, 38, 46, 0 |
2.0
(18.06)
|
2.8
(22.54)
|
-1.6
(20.95)
|
|
| ALT; Week 264; n=32, 38, 47, 0 |
3.3
(19.88)
|
0.7
(23.29)
|
2.0
(29.60)
|
|
| ALT; Week 276; n=31, 38, 45, 0 |
3.3
(19.97)
|
2.9
(31.30)
|
1.1
(23.92)
|
|
| ALT; Week 288; n=31, 38, 45, 0 |
6.6
(24.89)
|
1.2
(27.16)
|
1.9
(26.19)
|
|
| ALT; Week 300; n=30, 37, 44, 0 |
4.8
(25.46)
|
-1.4
(19.21)
|
-1.8
(24.06)
|
|
| ALT; Week 312; n=31, 34, 43, 0 |
5.5
(25.29)
|
7.6
(42.61)
|
0.0
(22.51)
|
|
| ALT; Week 324; n=3, 4, 3, 0 |
17.7
(40.15)
|
1.3
(8.73)
|
1.0
(4.36)
|
|
| AST; Week 2; n=58, 56, 58, 58 |
0.7
(6.11)
|
-1.3
(11.20)
|
-1.6
(8.85)
|
0.9
(58.63)
|
| AST; Week 4; n=58, 57, 59, 57 |
-1.0
(5.96)
|
-2.8
(8.97)
|
0.1
(14.56)
|
-2.9
(31.52)
|
| AST; Week 8; n=58, 55, 57, 54 |
4.2
(30.51)
|
1.5
(22.15)
|
5.3
(36.86)
|
-7.3
(29.65)
|
| AST; Week 12; n=58, 53, 57, 50 |
1.3
(10.43)
|
1.6
(21.65)
|
-1.7
(8.91)
|
-7.9
(32.18)
|
| AST; Week 16; n=57, 54, 57, 52 |
-0.7
(10.43)
|
1.9
(23.46)
|
-0.6
(8.03)
|
4.4
(79.53)
|
| AST; Week 20; n=56, 54, 55, 49 |
1.3
(18.94)
|
-3.1
(10.44)
|
4.6
(23.87)
|
-3.6
(41.56)
|
| AST; Week 24; n=56, 53, 56, 47 |
-1.4
(7.81)
|
-0.3
(15.64)
|
1.5
(15.03)
|
-2.1
(13.59)
|
| AST; Week 26; n=48, 50, 53, 45 |
3.3
(28.47)
|
-0.9
(16.10)
|
-1.7
(8.21)
|
-2.6
(17.81)
|
| AST; Week 28; n=51, 52, 52, 45 |
-2.0
(6.39)
|
-0.2
(15.51)
|
-1.9
(13.67)
|
-5.1
(15.42)
|
| AST; Week 32; n=52, 53, 55, 45 |
-2.7
(5.77)
|
-1.0
(16.15)
|
-1.4
(9.19)
|
-2.8
(17.86)
|
| AST; Week 36; n=52, 52, 55, 45 |
4.6
(38.77)
|
-2.1
(12.13)
|
-0.6
(11.86)
|
-1.9
(17.93)
|
| AST; Week 40; n=52, 53, 55, 44 |
0.1
(13.12)
|
-2.9
(10.87)
|
-0.5
(14.40)
|
-5.1
(14.94)
|
| AST; Week 48; n=51, 53, 54, 44 |
-3.3
(7.99)
|
-3.2
(12.28)
|
-3.0
(8.28)
|
-4.4
(16.67)
|
| AST; Week 60; n=48, 47, 53, 44 |
-0.9
(9.05)
|
-2.0
(13.06)
|
3.0
(18.70)
|
-3.2
(17.49)
|
| AST; Week 72; n=47, 47, 52, 42 |
-2.7
(6.70)
|
3.7
(24.41)
|
-0.5
(9.75)
|
-4.6
(15.69)
|
| AST; Week 84; n=46, 48, 52, 42 |
-2.2
(7.56)
|
2.0
(19.02)
|
-1.8
(9.46)
|
2.3
(40.93)
|
| AST; Week 96; n=45, 48, 52, 40 |
-0.8
(22.39)
|
20.5
(150.10)
|
-1.0
(12.58)
|
-0.3
(25.99)
|
| AST; Week 108; n=43, 46, 48, 0 |
-1.0
(10.89)
|
-4.0
(11.71)
|
0.6
(22.77)
|
|
| AST; Week 120; n=40, 45, 48, 0 |
0.1
(13.16)
|
-2.5
(13.44)
|
-2.4
(10.90)
|
|
| AST; Week 132; n=40, 46, 49, 0 |
-0.2
(11.50)
|
-3.9
(12.40)
|
0.7
(32.61)
|
|
| AST; Week 144; n=37, 45, 47, 0 |
-3.4
(8.19)
|
-4.3
(13.76)
|
-3.9
(9.45)
|
|
| AST; Week 156; n=37, 42, 49, 0 |
-3.0
(8.78)
|
-3.2
(13.94)
|
-4.1
(13.08)
|
|
| AST; Week 168; n=35, 43, 47, 0 |
-0.8
(8.95)
|
-3.4
(12.15)
|
-3.8
(13.44)
|
|
| AST; Week 180; n=36, 41, 47, 0 |
-1.9
(7.91)
|
-4.2
(12.71)
|
-2.9
(17.09)
|
|
| AST; Week 192; n=36, 39, 47, 0 |
-1.5
(8.89)
|
-5.3
(11.00)
|
0.1
(20.52)
|
|
| AST; Week 204; n=34, 39, 47, 0 |
-1.7
(7.88)
|
-4.8
(10.98)
|
-4.5
(12.04)
|
|
| AST; Week 216; n=33, 39, 46, 0 |
-2.7
(6.40)
|
-4.9
(11.54)
|
-4.3
(13.42)
|
|
| AST; Week 228; n=32, 39, 47, 0 |
13.5
(72.97)
|
-5.9
(11.78)
|
-2.8
(10.14)
|
|
| AST; Week 240; n=30, 39, 46, 0 |
-1.0
(21.51)
|
-5.3
(11.70)
|
-3.4
(11.32)
|
|
| AST; Week 252; n=31, 38, 46, 0 |
-2.2
(10.89)
|
-2.1
(15.31)
|
-3.9
(11.09)
|
|
| AST; Week 264; n=32, 38, 47, 0 |
-1.6
(10.61)
|
-4.3
(15.09)
|
-2.9
(12.87)
|
|
| AST; Week 276; n=31, 38, 45, 0 |
-1.5
(10.00)
|
-3.3
(14.38)
|
-1.4
(12.80)
|
|
| AST; Week 288; n=31, 38, 45, 0 |
-1.4
(11.87)
|
-3.6
(14.93)
|
-2.2
(12.98)
|
|
| AST; Week 300; n=30, 37, 44, 0 |
-2.0
(9.56)
|
-5.3
(13.01)
|
-4.1
(12.07)
|
|
| AST; Week 312; n=31, 34, 43, 0 |
11.7
(82.61)
|
-2.3
(17.39)
|
-0.3
(14.27)
|
|
| AST; Week 324; n=3, 4, 3, 0 |
2.7
(12.66)
|
-5.3
(14.59)
|
-6.7
(4.16)
|
|
| CK; Week 2; n=58, 56, 58, 58 |
40.0
(234.19)
|
-32.2
(664.29)
|
0.4
(183.47)
|
159.8
(3217.64)
|
| CK; Week 4; n=58, 57, 59, 57 |
-2.3
(125.78)
|
-82.0
(586.36)
|
-2.9
(227.73)
|
-120.3
(1656.37)
|
| CK; Week 8; n=58, 55, 57, 54 |
216.9
(1495.44)
|
115.8
(1625.63)
|
266.7
(1787.23)
|
-212.8
(1579.19)
|
| CK; Week 12; n=58, 53, 57, 51 |
120.6
(551.72)
|
39.8
(1035.75)
|
27.1
(208.15)
|
-220.1
(1656.33)
|
| CK; Week 16; n=57, 54, 57, 52 |
-2.0
(177.01)
|
156.3
(1399.82)
|
28.6
(218.04)
|
269.7
(3855.01)
|
| CK; Week 20; n=56, 54, 55, 49 |
144.2
(969.11)
|
-68.9
(542.73)
|
298.9
(1661.14)
|
135.3
(3115.23)
|
| CK; Week 24; n=56, 53, 56, 47 |
27.5
(241.96)
|
32.4
(800.50)
|
55.9
(252.05)
|
103.9
(482.18)
|
| CK; Week 26; n=48, 50, 53, 45 |
133.7
(612.97)
|
-16.3
(616.41)
|
54.4
(316.26)
|
21.2
(162.22)
|
| CK; Week 28; n=51, 52, 52, 45 |
9.8
(179.35)
|
74.1
(542.07)
|
96.8
(475.89)
|
4.1
(159.24)
|
| CK; Week 32; n=52, 53, 55, 45 |
3.1
(159.46)
|
-25.1
(605.67)
|
122.1
(364.15)
|
110.3
(794.67)
|
| CK; Week 36; n=52, 52, 55, 45 |
325.9
(1995.64)
|
-33.6
(572.93)
|
66.1
(276.38)
|
158.7
(625.32)
|
| CK; Week 40; n=52, 53, 55, 44 |
57.1
(350.15)
|
-48.6
(502.19)
|
103.5
(390.10)
|
3.8
(128.31)
|
| CK; Week 48; n=51, 53, 54, 44 |
-1.3
(173.80)
|
-54.7
(612.26)
|
28.6
(196.37)
|
2.8
(124.04)
|
| CK; Week 60; n=48, 47, 53, 44 |
115.4
(743.67)
|
-80.1
(598.41)
|
206.2
(880.62)
|
24.5
(158.37)
|
| CK; Week 72; n=47, 47, 52, 42 |
-19.8
(152.46)
|
53.8
(1031.26)
|
67.6
(311.66)
|
-14.3
(92.49)
|
| CK; Week 84; n=46, 48, 52, 42 |
-0.7
(147.67)
|
33.6
(900.48)
|
14.9
(211.36)
|
123.9
(598.22)
|
| CK; Week 96; n=45, 48, 52, 40 |
335.4
(2431.93)
|
-22.8
(768.54)
|
19.6
(249.41)
|
143.9
(903.29)
|
| CK; Week 108; n=43, 46, 48, 0 |
64.2
(339.96)
|
-88.5
(592.61)
|
100.3
(546.46)
|
|
| CK; Week 120; n=40, 45, 48, 0 |
11.5
(229.39)
|
-48.9
(614.32)
|
61.4
(304.98)
|
|
| CK; Week 132; n=40, 46, 49, 0 |
30.6
(198.34)
|
-41.3
(654.65)
|
649.6
(3895.73)
|
|
| CK; Week 144; n=37, 45, 47, 0 |
10.6
(143.04)
|
-72.4
(637.65)
|
68.7
(192.20)
|
|
| CK; Week 156; n=37, 42, 49, 0 |
-5.3
(178.55)
|
-87.9
(626.53)
|
73.3
(396.95)
|
|
| CK; Week 168; n=35, 43, 47, 0 |
27.7
(149.18)
|
-60.7
(648.64)
|
74.4
(492.75)
|
|
| CK; Week 180; n=36, 41, 47, 0 |
22.4
(120.72)
|
-16.4
(769.12)
|
62.8
(325.34)
|
|
| CK; Week 192; n=36, 39, 47, 0 |
5.2
(123.98)
|
-98.5
(666.21)
|
98.6
(393.41)
|
|
| CK; Week 204; n=34, 39, 47, 0 |
79.1
(253.58)
|
-101.8
(642.05)
|
48.3
(148.37)
|
|
| CK; Week 216; n=33, 39, 46, 0 |
43.2
(232.12)
|
-74.4
(658.64)
|
41.9
(177.16)
|
|
| CK; Week 228; n=32, 39, 47, 0 |
64.0
(332.07)
|
-129.0
(640.89)
|
40.4
(133.68)
|
|
| CK; Week 240; n=30, 39, 46, 0 |
1.2
(118.21)
|
-108.1
(646.43)
|
92.0
(285.12)
|
|
| CK; Week 252; n=31, 38, 46, 0 |
24.6
(96.40)
|
-110.1
(645.37)
|
62.5
(201.59)
|
|
| CK; Week 264; n=32, 38, 47, 0 |
1.9
(135.22)
|
-31.3
(819.97)
|
38.9
(137.90)
|
|
| CK; Week 276; n=31, 38, 45, 0 |
39.9
(258.45)
|
-126.5
(639.63)
|
146.4
(350.73)
|
|
| CK; Week 288; n=31, 38, 45, 0 |
21.6
(139.26)
|
-98.5
(642.79)
|
43.4
(172.08)
|
|
| CK; Week 300; n=30, 37, 44, 0 |
25.3
(129.65)
|
-100.7
(684.43)
|
56.0
(195.62)
|
|
| CK; Week 312; n=31, 34, 43, 0 |
727.5
(4047.61)
|
-141.3
(681.29)
|
209.4
(862.10)
|
|
| CK; Week 324; n=3, 4, 3, 0 |
-1.3
(168.42)
|
-195.0
(417.89)
|
102.7
(157.82)
|
| Title | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit |
|---|---|
| Description | Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Time Frame | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Creatinine; Week 2; n=58, 56, 58, 58 |
3.36
(7.519)
|
2.58
(7.273)
|
4.15
(6.508)
|
0.65
(7.483)
|
| Creatinine; Week 4; n=58, 57, 59, 57 |
2.24
(6.889)
|
2.50
(7.401)
|
4.08
(8.072)
|
-0.32
(5.817)
|
| Creatinine; Week 8; n=58, 55, 57, 54 |
2.38
(8.371)
|
2.06
(6.775)
|
3.44
(8.717)
|
-0.92
(9.006)
|
| Creatinine; Week 12; n=58, 53, 57, 51 |
3.39
(8.591)
|
1.59
(9.300)
|
3.79
(8.634)
|
-1.42
(9.022)
|
| Creatinine; Week 16; n=57, 54, 57, 52 |
2.91
(11.874)
|
1.10
(6.923)
|
2.09
(8.967)
|
-2.92
(7.744)
|
| Creatinine; Week 20; n=56, 54, 55, 49 |
2.54
(6.384)
|
0.85
(7.713)
|
5.29
(9.360)
|
-3.26
(8.085)
|
| Creatinine; Week 24; n=56, 53, 56, 47 |
2.52
(7.225)
|
2.44
(9.391)
|
4.45
(9.743)
|
-2.03
(15.306)
|
| Creatinine; Week 26; n=48, 50, 53, 45 |
2.74
(7.750)
|
1.80
(8.796)
|
6.03
(8.465)
|
-2.67
(9.311)
|
| Creatinine; Week 28; n=51, 52, 52, 45 |
2.22
(6.606)
|
2.80
(8.908)
|
5.01
(9.028)
|
-3.42
(8.042)
|
| Creatinine; Week 32; n=52, 53, 55, 45 |
3.36
(8.462)
|
1.69
(9.226)
|
5.00
(8.690)
|
-3.50
(7.887)
|
| Creatinine; Week 36; n=52, 52, 55, 45 |
3.11
(6.652)
|
3.41
(8.115)
|
6.00
(8.059)
|
-3.26
(7.392)
|
| Creatinine; Week 40; n=52, 53, 55, 44 |
2.83
(7.966)
|
2.36
(8.318)
|
4.76
(7.858)
|
-2.83
(9.423)
|
| Creatinine; Week 48; n=51, 53, 54, 44 |
2.75
(9.061)
|
2.18
(8.280)
|
4.47
(7.883)
|
-2.73
(8.533)
|
| Creatinine; Week 60; n=48, 47, 53, 44 |
3.28
(7.507)
|
2.30
(7.998)
|
4.46
(9.058)
|
-3.87
(7.866)
|
| Creatinine; Week 72; n=47, 47, 52, 42 |
3.89
(7.917)
|
4.71
(7.934)
|
6.59
(10.595)
|
-4.48
(8.461)
|
| Creatinine; Week 84; n=46, 48, 52, 42 |
4.58
(9.834)
|
3.80
(8.761)
|
6.53
(8.328)
|
-2.48
(8.697)
|
| Creatinine; Week 96; n=45, 48, 52, 40 |
1.90
(11.248)
|
5.34
(10.813)
|
7.76
(10.318)
|
-2.28
(10.222)
|
| Creatinine; Week 108; n=43, 46, 48, 0 |
5.87
(9.133)
|
5.18
(7.296)
|
7.26
(10.273)
|
|
| Creatinine; Week 120; n=40, 45, 48, 0 |
4.41
(8.648)
|
4.15
(7.099)
|
6.78
(11.811)
|
|
| Creatinine; Week 132; n=40, 46, 49, 0 |
3.76
(8.272)
|
4.02
(6.551)
|
4.99
(12.168)
|
|
| Creatinine; Week 144; n=37, 45, 47, 0 |
5.99
(11.083)
|
5.80
(6.861)
|
5.07
(10.449)
|
|
| Creatinine; Week 156; n=37, 42, 49, 0 |
5.28
(8.225)
|
6.36
(6.819)
|
5.16
(9.056)
|
|
| Creatinine; Week 168; n=35, 43, 47, 0 |
6.57
(8.702)
|
5.62
(8.355)
|
6.82
(9.644)
|
|
| Creatinine; Week 180; n=36, 41, 47, 0 |
5.89
(6.964)
|
5.08
(7.638)
|
5.91
(11.737)
|
|
| Creatinine; Week 192; n=36, 39, 47, 0 |
6.90
(9.792)
|
7.91
(9.528)
|
5.90
(11.316)
|
|
| Creatinine; Week 204; n=34, 39, 47, 0 |
6.21
(9.019)
|
6.46
(8.491)
|
5.16
(10.629)
|
|
| Creatinine; Week 216; n=33, 39, 46, 0 |
8.34
(7.736)
|
9.31
(10.863)
|
7.42
(8.996)
|
|
| Creatinine; Week 228; n=32, 39, 47, 0 |
7.16
(10.365)
|
7.19
(7.388)
|
6.61
(10.415)
|
|
| Creatinine; Week 240; n=30, 39, 46, 0 |
8.48
(10.016)
|
7.33
(9.459)
|
7.08
(10.649)
|
|
| Creatinine; Week 252; n=31, 38, 46, 0 |
6.96
(8.206)
|
7.52
(9.245)
|
7.64
(11.727)
|
|
| Creatinine; Week 264; n=32, 38, 47, 0 |
5.97
(7.510)
|
7.10
(9.486)
|
6.99
(12.140)
|
|
| Creatinine; Week 276; n=31, 38, 45, 0 |
7.89
(8.309)
|
5.84
(10.581)
|
6.19
(10.418)
|
|
| Creatinine; Week 288; n=31, 38, 45, 0 |
8.81
(8.348)
|
7.84
(9.546)
|
6.20
(12.890)
|
|
| Creatinine; Week 300; n=30, 37, 44, 0 |
10.49
(8.321)
|
9.16
(9.580)
|
8.19
(12.114)
|
|
| Creatinine; Week 312; n=31, 34, 43, 0 |
7.98
(8.645)
|
7.86
(9.096)
|
7.10
(12.061)
|
|
| Creatinine; Week 324; n=3, 4, 3, 0 |
15.90
(6.636)
|
9.75
(8.155)
|
5.03
(4.007)
|
|
| T. Bilirubin; Week 2; n=58, 56, 58, 58 |
0.0
(3.20)
|
-0.3
(2.71)
|
-0.4
(4.89)
|
-3.0
(3.82)
|
| T. Bilirubin; Week 4; n=58, 57, 59, 57 |
0.1
(3.39)
|
-0.3
(3.90)
|
-0.8
(5.90)
|
-3.4
(4.06)
|
| T. Bilirubin; Week 8; n=58, 55, 57, 54 |
0.0
(3.99)
|
-0.5
(3.83)
|
-0.6
(5.62)
|
-3.4
(4.24)
|
| T. Bilirubin; Week 12; n=58, 53, 57, 51 |
0.4
(5.43)
|
-0.9
(3.77)
|
-0.5
(5.61)
|
-2.4
(3.75)
|
| T. Bilirubin; Week 16; n=57, 54, 57, 52 |
0.4
(3.96)
|
-1.2
(3.74)
|
-0.2
(4.93)
|
-2.4
(3.79)
|
| T. Bilirubin; Week 20; n=56, 54, 55, 49 |
-0.1
(3.96)
|
-0.7
(3.63)
|
-0.4
(7.27)
|
-2.6
(3.83)
|
| T. Bilirubin; Week 24; n=56, 53, 56, 47 |
0.5
(4.26)
|
0.2
(4.45)
|
-0.7
(5.69)
|
-2.9
(3.86)
|
| T. Bilirubin; Week 26; n=48, 50, 53, 45 |
1.1
(4.97)
|
0.5
(3.81)
|
1.0
(5.80)
|
-2.7
(3.44)
|
| T. Bilirubin; Week 28; n=51, 52, 52, 45 |
1.1
(4.39)
|
0.7
(5.19)
|
0.5
(5.25)
|
-2.8
(4.01)
|
| T. Bilirubin; Week 32; n=52, 53, 55, 45 |
0.7
(3.79)
|
0.2
(4.99)
|
0.9
(6.82)
|
-2.6
(3.78)
|
| T. Bilirubin; Week 36; n=52, 52, 55, 45 |
1.2
(4.94)
|
0.6
(4.92)
|
1.4
(6.40)
|
-2.7
(3.62)
|
| T. Bilirubin; Week 40; n=52, 53, 55, 44 |
1.6
(5.03)
|
1.7
(4.75)
|
1.5
(6.30)
|
-2.9
(3.67)
|
| T. Bilirubin; Week 48; n=51, 53, 54, 44 |
0.9
(4.58)
|
0.1
(4.51)
|
-0.3
(5.37)
|
-2.6
(3.80)
|
| T. Bilirubin; Week 60; n=48, 47, 53, 44 |
1.9
(4.31)
|
0.0
(4.78)
|
0.9
(6.56)
|
-2.2
(3.86)
|
| T. Bilirubin; Week 72; n=47, 47, 52, 42 |
1.5
(6.05)
|
0.1
(4.59)
|
0.6
(6.36)
|
-2.7
(3.69)
|
| T. Bilirubin; Week 84; n=46, 48, 52, 42 |
2.3
(5.09)
|
0.1
(5.07)
|
1.2
(5.49)
|
-2.6
(4.27)
|
| T. Bilirubin; Week 96; n=45, 48, 52, 40 |
1.0
(4.15)
|
0.0
(5.80)
|
1.7
(5.42)
|
-2.5
(3.92)
|
| T. Bilirubin; Week 108; n=43, 46, 48, 0 |
0.7
(4.86)
|
1.4
(6.34)
|
0.8
(5.89)
|
|
| T. Bilirubin; Week 120; n=40, 45, 48, 0 |
0.9
(4.96)
|
1.1
(4.72)
|
1.3
(7.40)
|
|
| T. Bilirubin; Week 132; n=40, 46, 49, 0 |
1.0
(6.16)
|
2.0
(8.03)
|
1.1
(6.40)
|
|
| T. Bilirubin; Week 144; n=37, 45, 47, 0 |
0.7
(4.70)
|
1.1
(7.00)
|
0.4
(6.50)
|
|
| T. Bilirubin; Week 156; n=37, 42, 49, 0 |
1.6
(5.07)
|
1.0
(5.23)
|
1.0
(6.93)
|
|
| T. Bilirubin; Week 168; n=35, 43, 47, 0 |
1.1
(5.37)
|
0.8
(4.19)
|
1.4
(5.94)
|
|
| T. Bilirubin; Week 180; n=36, 41, 47, 0 |
1.1
(5.54)
|
0.0
(4.29)
|
1.0
(7.42)
|
|
| T. Bilirubin; Week 192; n=36, 39, 47, 0 |
0.7
(5.88)
|
0.3
(4.80)
|
0.9
(6.18)
|
|
| T. Bilirubin; Week 204; n=34, 39, 47, 0 |
1.1
(5.31)
|
0.7
(3.71)
|
0.6
(6.61)
|
|
| T. Bilirubin; Week 216; n=33, 39, 46, 0 |
0.5
(5.08)
|
0.8
(6.69)
|
0.3
(5.91)
|
|
| T. Bilirubin; Week 228; n=32, 39, 47, 0 |
1.6
(4.61)
|
0.5
(3.77)
|
-0.3
(5.71)
|
|
| T. Bilirubin; Week 240; n=30, 39, 46, 0 |
1.2
(4.92)
|
0.9
(4.72)
|
-0.1
(4.83)
|
|
| T. Bilirubin; Week 252; n=31, 38, 46, 0 |
1.4
(5.71)
|
2.0
(6.03)
|
0.2
(6.21)
|
|
| T. Bilirubin; Week 264; n=32, 38, 47, 0 |
0.4
(5.76)
|
2.9
(8.95)
|
-0.1
(6.11)
|
|
| T. Bilirubin; Week 276; n=31, 38, 45, 0 |
0.7
(3.52)
|
2.8
(10.40)
|
0.9
(6.46)
|
|
| T. Bilirubin; Week 288; n=31, 38, 45, 0 |
0.5
(5.06)
|
1.9
(7.87)
|
0.0
(6.10)
|
|
| T. Bilirubin; Week 300; n=30, 37, 44, 0 |
1.1
(4.22)
|
1.7
(8.78)
|
0.9
(5.18)
|
|
| T. Bilirubin; Week 312; n=31, 34, 43, 0 |
1.4
(5.30)
|
1.1
(7.12)
|
0.8
(5.52)
|
|
| T. Bilirubin; Week 324; n=3, 4, 3, 0 |
5.3
(4.16)
|
5.5
(11.47)
|
0.7
(4.16)
|
| Title | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
|---|---|
| Description | Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Time Frame | Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Week 2; n=1, 1, 0, 3 |
-3.0
(NA)
|
-10.0
(NA)
|
-0.7
(0.58)
|
|
| Week 4; n=58, 57, 59, 57 |
-1.4
(12.20)
|
-3.7
(12.18)
|
-4.9
(14.83)
|
-0.1
(10.06)
|
| Week 8; n=2, 1, 1, 1 |
5.5
(26.16)
|
-1.0
(NA)
|
7.0
(NA)
|
0.0
(NA)
|
| Week 16; n=55, 53, 56, 49 |
2.2
(37.66)
|
0.2
(15.60)
|
-2.7
(13.89)
|
3.4
(12.94)
|
| Week 20; n=2, 0, 0, 1 |
8.0
(7.07)
|
4.0
(NA)
|
||
| Week 24; n=52, 53, 55, 46 |
-2.7
(22.03)
|
-6.4
(34.13)
|
-5.8
(14.77)
|
4.8
(15.66)
|
| Week 26; n=0, 1, 0, 0 |
-7.0
(NA)
|
|||
| Week 40; n=0, 1, 0, 0 |
-95.0
(NA)
|
|||
| Week 48; n=51, 50, 54, 44 |
-2.6
(12.72)
|
-1.1
(16.63)
|
-4.5
(14.27)
|
0.4
(19.04)
|
| Week 60; n=0, 0, 0, 1 |
16.0
(NA)
|
|||
| Week 96; n=45, 48, 52, 40 |
2.2
(31.70)
|
-2.4
(20.43)
|
-9.0
(16.95)
|
5.1
(22.48)
|
| Week 180; n=1, 0, 0, 0 |
1.0
(NA)
|
|||
| Week 204; n=0, 1, 0, 0 |
-23.0
(NA)
|
|||
| Week 252; n=0, 1, 0, 0 |
0.0
(NA)
|
|||
| Week 264; n=0, 0, 1, 0 |
-143.0
(NA)
|
| Title | Change From Baseline in Hemoglobin Level Over Time by Visit |
|---|---|
| Description | Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Time Frame | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Week 2; n=57, 56, 59, 59 |
0.1
(6.66)
|
0.0
(6.25)
|
-0.7
(6.61)
|
0.7
(6.90)
|
| Week 4; n=57, 57, 59, 57 |
-0.2
(6.41)
|
0.5
(5.61)
|
0.6
(7.67)
|
0.7
(6.40)
|
| Week 8; n=58, 56, 56, 55 |
2.7
(9.19)
|
4.8
(7.23)
|
2.0
(8.99)
|
2.0
(9.18)
|
| Week 12; n=58, 53, 57, 51 |
2.0
(8.27)
|
3.9
(7.84)
|
2.6
(9.59)
|
2.8
(8.57)
|
| Week 16; n=57, 54, 57, 52 |
1.1
(7.58)
|
3.5
(7.55)
|
2.3
(9.61)
|
1.1
(9.22)
|
| Week 20; n=56, 54, 55, 49 |
2.1
(8.78)
|
3.8
(9.28)
|
3.1
(9.66)
|
0.8
(9.22)
|
| Week 24; n=56, 53, 56, 47 |
2.6
(9.17)
|
4.8
(7.66)
|
3.6
(11.04)
|
1.9
(8.16)
|
| Week 26; n=48, 50, 53, 45 |
1.8
(7.68)
|
3.4
(8.00)
|
2.5
(9.17)
|
2.2
(8.11)
|
| Week 28; n=50, 52, 52, 45 |
1.7
(8.51)
|
4.0
(7.93)
|
1.5
(8.50)
|
0.1
(10.50)
|
| Week 32; n=51, 53, 55, 45 |
1.6
(8.64)
|
3.1
(8.71)
|
3.5
(8.49)
|
0.6
(8.92)
|
| Week 36; n=52, 53, 55, 44 |
0.3
(10.21)
|
2.9
(9.69)
|
2.7
(11.59)
|
-0.8
(9.79)
|
| Week 40; n=51, 53, 55, 45 |
0.5
(11.44)
|
2.2
(8.56)
|
2.1
(9.46)
|
-0.2
(7.67)
|
| Week 48; n=51, 53, 54, 44 |
1.2
(9.84)
|
2.7
(8.40)
|
-0.5
(12.03)
|
0.0
(9.52)
|
| Week 60; n=48, 47, 52, 44 |
2.6
(11.23)
|
4.7
(8.73)
|
2.2
(11.45)
|
2.3
(9.18)
|
| Week 72; n=47, 48, 52, 42 |
1.8
(11.28)
|
4.5
(7.39)
|
2.4
(10.08)
|
2.4
(9.15)
|
| Week 84; n=46, 48, 51, 42 |
3.3
(11.53)
|
4.0
(8.37)
|
3.0
(11.34)
|
1.7
(9.65)
|
| Week 96; n=46, 46, 52, 41 |
2.7
(13.41)
|
3.3
(6.94)
|
3.6
(10.11)
|
1.9
(10.06)
|
| Week 108; n=43, 46, 49, 0 |
4.0
(11.77)
|
3.4
(9.42)
|
3.0
(10.98)
|
|
| Week 120; n=41, 46, 49, 0 |
4.2
(11.11)
|
4.7
(8.72)
|
2.1
(11.39)
|
|
| Week 132; n=40, 46, 49, 0 |
3.5
(10.89)
|
3.0
(9.90)
|
2.5
(12.41)
|
|
| Week 144; n=37, 45, 46, 0 |
4.0
(12.08)
|
2.6
(10.64)
|
2.3
(11.37)
|
|
| Week 156; n=37, 42, 49, 0 |
4.0
(11.55)
|
5.1
(9.76)
|
2.7
(11.88)
|
|
| Week 168; n=35, 43, 47, 0 |
6.3
(12.60)
|
6.0
(10.91)
|
4.8
(10.60)
|
|
| Week 180; n=36, 41, 47, 0 |
5.5
(11.79)
|
4.0
(9.23)
|
2.7
(11.68)
|
|
| Week 192; n=35, 40, 47, 0 |
3.3
(13.07)
|
3.5
(9.55)
|
3.0
(11.51)
|
|
| Week 204; n=34, 39, 47, 0 |
4.5
(12.73)
|
4.7
(9.84)
|
3.2
(11.65)
|
|
| Week 216; n=32, 39, 44, 0 |
4.7
(14.10)
|
4.1
(9.97)
|
3.4
(10.60)
|
|
| Week 228; n=31, 39, 47, 0 |
5.1
(13.32)
|
4.8
(10.55)
|
3.1
(10.53)
|
|
| Week 240; n=32, 39, 47, 0 |
6.2
(14.38)
|
5.8
(10.64)
|
2.1
(11.70)
|
|
| Week 252; n=31, 36, 45, 0 |
6.2
(14.98)
|
6.4
(11.76)
|
5.8
(10.33)
|
|
| Week 264; n=32, 38, 46, 0 |
6.3
(14.69)
|
6.0
(9.28)
|
5.5
(11.07)
|
|
| Week 276; n=31, 38, 46, 0 |
6.6
(14.67)
|
5.5
(11.06)
|
5.4
(10.02)
|
|
| Week 288; n=30, 38, 44, 0 |
7.3
(12.51)
|
6.8
(11.38)
|
6.9
(10.82)
|
|
| Week 300; n=30, 37, 43, 0 |
4.6
(15.39)
|
5.1
(10.47)
|
5.5
(11.56)
|
|
| Week 312; n=31, 33, 42, 0 |
7.0
(13.56)
|
6.1
(9.29)
|
8.0
(10.10)
|
|
| Week 324; n=3, 4, 2, 0 |
4.3
(9.07)
|
10.0
(14.33)
|
20.5
(7.78)
|
| Title | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit |
|---|---|
| Description | Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Time Frame | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| T. neutrophils; Week 2; n=57, 56, 59, 59 |
0.042
(1.0528)
|
-0.084
(1.4018)
|
0.104
(1.0318)
|
0.716
(1.4565)
|
| T. neutrophils; Week 4; n=57, 57, 59, 57 |
0.038
(1.2691)
|
-0.083
(1.2859)
|
0.155
(1.0877)
|
0.375
(1.5303)
|
| T. neutrophils; Week 8; n=58, 56, 56, 55 |
0.251
(1.0956)
|
-0.066
(1.3186)
|
0.341
(1.2077)
|
0.273
(0.8715)
|
| T. neutrophils; Week 12; n=58, 53, 57, 51 |
0.138
(1.2352)
|
0.040
(1.4855)
|
0.359
(1.3585)
|
0.525
(1.5661)
|
| T. neutrophils; Week 16; n=57, 54, 57, 52 |
0.388
(1.7066)
|
-0.156
(1.2694)
|
0.203
(1.0459)
|
0.367
(1.2022)
|
| T. neutrophils; Week 20; n=56, 54, 55, 49 |
0.270
(1.3671)
|
0.032
(1.3837)
|
0.525
(1.6689)
|
0.740
(1.7181)
|
| T. neutrophils; Week 24; n=56, 53, 56, 47 |
0.462
(1.1725)
|
0.109
(1.7578)
|
0.406
(1.0404)
|
0.637
(1.5583)
|
| T. neutrophils; Week 26; n=48, 50, 53, 45 |
0.120
(0.8908)
|
0.052
(1.7443)
|
0.375
(1.1565)
|
0.449
(1.3271)
|
| T. neutrophils; Week 28; n=50, 52, 52, 45 |
0.496
(1.1330)
|
0.213
(1.4523)
|
0.502
(1.2817)
|
0.446
(1.1851)
|
| T. neutrophils; Week 32; n=51, 53, 55, 45 |
0.071
(1.3373)
|
0.149
(1.5137)
|
0.692
(1.4994)
|
0.717
(1.5595)
|
| T. neutrophils; Week 36; n=52, 53, 55, 44 |
0.420
(1.4246)
|
0.029
(1.7516)
|
0.535
(1.0695)
|
0.414
(1.3998)
|
| T. neutrophils; Week 40; n=51, 53, 55, 45 |
0.430
(1.4711)
|
0.178
(1.3099)
|
0.575
(1.0510)
|
0.730
(1.4181)
|
| T. neutrophils; Week 48; n=51, 53, 54, 44 |
0.386
(1.3376)
|
0.245
(1.5695)
|
0.534
(1.3432)
|
0.665
(1.6752)
|
| T. neutrophils; Week 60; n=48, 47, 52, 44 |
0.374
(1.4938)
|
0.458
(1.6323)
|
0.711
(0.9216)
|
0.800
(1.4058)
|
| T. neutrophils; Week 72; n=47, 48, 52, 42 |
0.383
(1.6125)
|
0.274
(1.5663)
|
0.666
(1.2125)
|
0.892
(1.9492)
|
| T. neutrophils; Week 84; n=46, 48, 51, 42 |
0.410
(1.6209)
|
0.528
(1.6303)
|
1.006
(1.4287)
|
0.790
(1.7937)
|
| T. neutrophils; Week 96; n=46, 46, 52, 41 |
0.631
(1.3478)
|
0.698
(1.8981)
|
0.997
(1.3089)
|
0.831
(1.4347)
|
| T. neutrophils; Week 108; n=43, 46, 49, 0 |
0.623
(1.7946)
|
0.570
(1.5706)
|
1.006
(1.6122)
|
|
| T. neutrophils; Week 120; n=41, 46, 49, 0 |
0.372
(1.7590)
|
0.650
(1.8334)
|
0.769
(1.6486)
|
|
| T. neutrophils; Week 132; n=40, 46, 49, 0 |
0.777
(2.1995)
|
0.405
(1.6979)
|
0.671
(1.0761)
|
|
| T. neutrophils; Week 144; n=37, 45, 46, 0 |
0.672
(1.3974)
|
0.468
(1.6210)
|
0.831
(1.4397)
|
|
| T. neutrophils; Week 156; n=37, 42, 49, 0 |
0.762
(1.7331)
|
0.418
(1.6395)
|
1.095
(1.2219)
|
|
| T. neutrophils; Week 168; n=35, 43, 47, 0 |
0.588
(1.5738)
|
0.534
(1.6710)
|
1.011
(1.2304)
|
|
| T. neutrophils; Week 180; n=36, 41, 47, 0 |
0.769
(1.4717)
|
0.405
(1.7183)
|
0.840
(1.0957)
|
|
| T. neutrophils; Week 192; n=35, 40, 47, 0 |
0.490
(1.3807)
|
0.594
(1.7286)
|
0.722
(1.2591)
|
|
| T. neutrophils; Week 204; n=34, 39, 47, 0 |
0.618
(1.7745)
|
0.648
(1.7939)
|
0.821
(1.4259)
|
|
| T. neutrophils; Week 216; n=32, 39, 43, 0 |
0.543
(1.7307)
|
0.588
(1.5854)
|
0.914
(1.4470)
|
|
| T. neutrophils; Week 228; n=30, 39, 47, 0 |
0.780
(1.7170)
|
0.789
(1.6779)
|
0.819
(1.1182)
|
|
| T. neutrophils; Week 240; n=32, 39, 47, 0 |
0.508
(1.4277)
|
0.813
(1.7505)
|
1.083
(2.3145)
|
|
| T. neutrophils; Week 252; n=31, 36, 45, 0 |
0.268
(1.4164)
|
0.761
(1.5531)
|
0.812
(1.3345)
|
|
| T. neutrophils; Week 264; n=32, 38, 46, 0 |
0.475
(1.7483)
|
0.761
(1.7316)
|
1.176
(1.6844)
|
|
| T. neutrophils; Week 276; n=31, 38, 45, 0 |
0.400
(1.6597)
|
0.627
(1.8500)
|
1.106
(1.3666)
|
|
| T. neutrophils; Week 288; n=30, 38, 44, 0 |
0.456
(1.8521)
|
0.673
(1.9230)
|
0.913
(1.5880)
|
|
| T. neutrophils; Week 300; n=30, 37, 43, 0 |
0.139
(1.2243)
|
0.455
(1.4957)
|
0.699
(1.1030)
|
|
| T. neutrophils; Week 312; n=31, 33, 41, 0 |
0.243
(1.3595)
|
0.417
(1.7807)
|
0.564
(1.1666)
|
|
| T. neutrophils; Week 324; n=3, 4, 2, 0 |
0.860
(2.7921)
|
0.315
(1.0660)
|
0.960
(0.4950)
|
|
| Platelet count; Week 2; n=57, 56, 59, 59 |
11.0
(30.21)
|
16.6
(27.48)
|
14.3
(22.17)
|
17.1
(33.56)
|
| Platelet count; Week 4; n=57, 57, 59, 57 |
9.9
(27.70)
|
20.1
(30.52)
|
14.1
(21.35)
|
15.6
(38.98)
|
| Platelet count; Week 8; n=58, 56, 56, 55 |
10.3
(26.33)
|
25.9
(33.21)
|
18.4
(27.51)
|
10.3
(36.86)
|
| Platelet count; Week 12; n=58, 53, 57, 51 |
13.7
(28.85)
|
14.6
(35.00)
|
17.7
(33.02)
|
11.2
(43.26)
|
| Platelet count; Week 16; n=57, 54, 57, 52 |
16.5
(36.43)
|
11.3
(30.85)
|
17.9
(34.32)
|
9.3
(40.36)
|
| Platelet count; Week 20; n=56, 54, 55, 49 |
17.2
(32.75)
|
14.5
(29.72)
|
13.7
(32.98)
|
17.1
(43.06)
|
| Platelet count; Week 24; n=56, 53, 56, 47 |
12.0
(31.51)
|
18.4
(34.30)
|
19.3
(27.64)
|
23.9
(49.14)
|
| Platelet count; Week 26; n=48, 50, 53, 45 |
8.3
(32.59)
|
11.2
(36.32)
|
10.3
(30.94)
|
17.5
(40.38)
|
| Platelet count; Week 28; n=50, 52, 52, 45 |
6.6
(33.00)
|
15.8
(34.97)
|
17.8
(27.83)
|
17.2
(44.39)
|
| Platelet count; Week 32; n=51, 52, 55, 45 |
7.7
(41.79)
|
11.6
(36.27)
|
15.4
(27.19)
|
13.8
(38.26)
|
| Platelet count; Week 36; n=52, 53, 55, 44 |
5.2
(39.32)
|
10.8
(39.28)
|
11.8
(32.72)
|
12.3
(43.83)
|
| Platelet count; Week 40; n=51, 53, 54, 45 |
11.1
(44.07)
|
8.9
(31.95)
|
7.8
(31.86)
|
18.9
(36.94)
|
| Platelet count; Week 48; n=51, 52, 53, 44 |
12.5
(41.82)
|
20.0
(38.20)
|
17.6
(38.70)
|
20.6
(42.78)
|
| Platelet count; Week 60; n=48, 47, 51, 44 |
20.9
(39.25)
|
18.7
(34.22)
|
26.6
(37.23)
|
30.8
(43.09)
|
| Platelet count; Week 72; n=47, 48, 52, 42 |
23.7
(37.03)
|
22.8
(32.35)
|
22.7
(35.13)
|
28.3
(37.19)
|
| Platelet count; Week 84; n=46, 48, 51, 42 |
13.6
(42.78)
|
17.2
(32.00)
|
21.1
(38.36)
|
18.9
(44.07)
|
| Platelet count; Week 96; n=46, 45, 51, 41 |
25.9
(39.73)
|
20.8
(39.00)
|
21.7
(36.57)
|
17.5
(40.11)
|
| Platelet count; Week 108; n=43, 46, 49, 0 |
24.5
(44.43)
|
24.6
(30.23)
|
33.1
(46.23)
|
|
| Platelet count; Week 120; n=41, 46, 49, 0 |
23.8
(48.05)
|
26.9
(33.58)
|
20.4
(31.47)
|
|
| Platelet count; Week 132; n=40, 46, 48, 0 |
16.8
(33.67)
|
21.0
(35.98)
|
32.2
(35.34)
|
|
| Platelet count; Week 144; n=37, 45, 44, 0 |
27.1
(50.68)
|
23.2
(31.97)
|
33.5
(54.61)
|
|
| Platelet count; Week 156; n=37, 42, 47, 0 |
26.6
(53.14)
|
30.6
(37.65)
|
41.2
(47.37)
|
|
| Platelet count; Week 168; n=35, 43, 46, 0 |
34.9
(43.78)
|
36.4
(37.72)
|
40.0
(50.19)
|
|
| Platelet count; Week 180; n=36, 41, 46, 0 |
28.4
(48.03)
|
27.6
(36.53)
|
45.4
(54.46)
|
|
| Platelet count; Week 192; n=35, 40, 46, 0 |
34.7
(58.72)
|
24.6
(37.42)
|
27.9
(45.02)
|
|
| Platelet count; Week 204; n=34, 39, 45, 0 |
33.9
(59.13)
|
26.4
(31.26)
|
37.6
(45.21)
|
|
| Platelet count; Week 216; n=32, 39, 44, 0 |
28.1
(48.97)
|
25.2
(31.60)
|
33.5
(44.09)
|
|
| Platelet count; Week 228; n=31, 39, 46, 0 |
28.7
(49.38)
|
27.1
(35.77)
|
29.1
(41.22)
|
|
| Platelet count; Week 240; n=32, 39, 47, 0 |
27.2
(52.69)
|
26.2
(31.38)
|
27.4
(42.22)
|
|
| Platelet count; Week 252; n=31, 36, 44, 0 |
15.9
(48.02)
|
15.4
(31.97)
|
30.8
(39.37)
|
|
| Platelet count; Week 264; n=32, 38, 45, 0 |
27.9
(48.97)
|
23.2
(29.82)
|
32.8
(43.26)
|
|
| Platelet count; Week 276; n=31, 38, 45, 0 |
48.4
(55.68)
|
34.5
(34.41)
|
45.8
(41.35)
|
|
| Platelet count; Week 288; n=30, 38, 43, 0 |
44.1
(60.21)
|
35.5
(34.89)
|
46.7
(43.13)
|
|
| Platelet count; Week 300; n=30, 37, 40, 0 |
28.5
(55.51)
|
26.8
(36.02)
|
45.4
(39.15)
|
|
| Platelet count; Week 312; n=31, 33, 41, 0 |
27.3
(52.62)
|
30.9
(34.28)
|
35.3
(37.26)
|
|
| Platelet count; Week 324; n=3, 4, 2, 0 |
31.7
(17.47)
|
8.3
(7.46)
|
2.0
(9.90)
|
|
| WBC count; Week 2; n=57, 56, 59, 59 |
0.19
(1.176)
|
0.13
(1.506)
|
0.31
(1.314)
|
0.69
(1.606)
|
| WBC count; Week 4; n=57, 57, 59, 57 |
0.16
(1.493)
|
0.02
(1.435)
|
0.30
(1.263)
|
0.29
(1.753)
|
| WBC count; Week 8; n=58, 56, 56, 55 |
0.37
(1.298)
|
0.15
(1.595)
|
0.48
(1.283)
|
0.27
(1.123)
|
| WBC; Week 12; n=58, 53, 57, 51 |
0.32
(1.427)
|
0.28
(1.696)
|
0.73
(1.375)
|
0.54
(1.734)
|
| WBC count; Week 16; n=57, 54, 57, 52 |
0.45
(1.806)
|
0.02
(1.554)
|
0.36
(1.080)
|
0.36
(1.542)
|
| WBC count; Week 20; n=56, 54, 55, 49 |
0.36
(1.510)
|
0.23
(1.523)
|
0.77
(1.848)
|
0.78
(1.821)
|
| WBC count; Week 24; n=56, 53, 56, 47 |
0.47
(1.245)
|
0.34
(2.060)
|
0.64
(1.226)
|
0.55
(1.822)
|
| WBC count; Week 26; n=48, 50, 53, 45 |
0.19
(1.130)
|
0.26
(2.039)
|
0.66
(1.257)
|
0.35
(1.578)
|
| WBC count; Week 28; n=50, 52, 52, 45 |
0.67
(1.412)
|
0.42
(1.685)
|
0.69
(1.428)
|
0.39
(1.416)
|
| WBC count; Week 32; n=51, 53, 55, 45 |
0.25
(1.598)
|
0.45
(1.767)
|
0.93
(1.704)
|
0.71
(1.820)
|
| WBC count; Week 36; n=52, 53, 55, 44 |
0.56
(1.532)
|
0.30
(2.068)
|
0.92
(1.178)
|
0.36
(1.547)
|
| WBC count; Week 40; n=51, 53, 55, 45 |
0.57
(1.668)
|
0.42
(1.654)
|
0.81
(1.205)
|
0.75
(1.680)
|
| WBC count; Week 48; n=51, 53, 54, 44 |
0.43
(1.499)
|
0.53
(1.912)
|
0.78
(1.447)
|
0.73
(1.874)
|
| WBC count; Week 60; n=48, 47, 52, 44 |
0.60
(1.774)
|
0.76
(1.686)
|
1.04
(1.160)
|
0.95
(1.735)
|
| WBC count; Week 72; n=47, 48, 52, 42 |
0.63
(1.932)
|
0.56
(1.917)
|
1.09
(1.378)
|
1.02
(2.280)
|
| WBC count; Week 84; n=46, 48, 51, 42 |
0.71
(1.805)
|
0.96
(1.914)
|
1.43
(1.622)
|
0.95
(1.893)
|
| WBC count; Week 96; n=46, 46, 52, 41 |
0.95
(1.687)
|
1.01
(2.069)
|
1.38
(1.405)
|
0.92
(1.624)
|
| WBC count; Week 108; n=43, 46, 49, 0 |
0.89
(2.190)
|
0.90
(1.714)
|
1.35
(1.749)
|
|
| WBC count; Week 120; n=41, 46, 49, 0 |
0.59
(1.931)
|
1.01
(1.988)
|
1.16
(1.632)
|
|
| WBC count; Week 132; n=40, 46, 49, 0 |
0.92
(2.274)
|
0.71
(1.958)
|
1.02
(1.103)
|
|
| WBC count; Week 144; n=37, 45, 46, 0 |
0.91
(1.667)
|
0.82
(1.727)
|
1.22
(1.785)
|
|
| WBC count; Week 156; n=37, 42, 49, 0 |
1.05
(2.056)
|
0.75
(1.797)
|
1.64
(1.291)
|
|
| WBC count; Week 168; n=35, 43, 47, 0 |
0.97
(1.859)
|
0.97
(1.748)
|
1.58
(1.472)
|
|
| WBC count; Week 180; n=36, 41, 47, 0 |
1.07
(1.778)
|
0.69
(1.902)
|
1.33
(1.485)
|
|
| WBC count; Week 192; n=35, 40, 47, 0 |
0.61
(1.645)
|
0.89
(1.972)
|
1.11
(1.428)
|
|
| WBC count; Week 204; n=34, 39, 47, 0 |
0.98
(2.042)
|
0.95
(1.823)
|
1.24
(1.554)
|
|
| WBC count; Week 216; n=32, 39, 43, 0 |
0.88
(2.175)
|
1.01
(1.859)
|
1.37
(1.656)
|
|
| WBC count; Week 228; n=31, 39, 47, 0 |
0.98
(1.970)
|
1.13
(1.918)
|
1.31
(1.329)
|
|
| WBC count; Week 240; n=32, 39, 47, 0 |
0.79
(1.851)
|
1.15
(1.942)
|
1.53
(2.455)
|
|
| WBC count; Week 252; n=31, 36, 45, 0 |
0.66
(1.649)
|
1.10
(1.814)
|
1.17
(1.531)
|
|
| WBC count; Week 264; n=32, 38, 46, 0 |
0.62
(1.798)
|
1.21
(1.985)
|
1.66
(2.030)
|
|
| WBC count; Week 276; n=31, 38, 45, 0 |
0.92
(1.985)
|
1.04
(2.056)
|
1.57
(1.721)
|
|
| WBC count; Week 288; n=30, 38, 44, 0 |
0.92
(2.188)
|
1.13
(2.293)
|
1.32
(1.908)
|
|
| WBC count; Week 300; n=30, 37, 43, 0 |
0.58
(1.762)
|
0.77
(1.856)
|
1.02
(1.321)
|
|
| WBC count; Week 312; n=31, 33, 41, 0 |
0.57
(1.732)
|
0.70
(2.051)
|
0.95
(1.274)
|
|
| WBC count; Week 324; n=3, 4, 2, 0 |
1.97
(3.075)
|
0.53
(0.984)
|
-0.05
(1.626)
|
| Title | Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events |
|---|---|
| Description | AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. |
| Time Frame | Up to Week 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Number [Percentage of participants] |
7
11.7%
|
7
11.7%
|
7
11.5%
|
15
24.2%
|
| Title | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings |
|---|---|
| Description | Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented. |
| Time Frame | Up to Week 324 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants with data available at the specified time points were analyzed. |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Count of Participants [Participants] |
25
41.7%
|
19
31.7%
|
15
24.6%
|
10
16.1%
|
| Title | Number of Participants With AEs and SAEs-Induction Phase |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. |
| Time Frame | Up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Any AE |
54
90%
|
54
90%
|
55
90.2%
|
59
95.2%
|
| Any SAE |
2
3.3%
|
0
0%
|
2
3.3%
|
2
3.2%
|
| Title | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase |
|---|---|
| Description | Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Time Frame | Up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| ALT; Grade 1 |
3
5%
|
4
6.7%
|
13
21.3%
|
8
12.9%
|
| ALT; Grade 2 |
1
1.7%
|
5
8.3%
|
0
0%
|
4
6.5%
|
| ALT; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| ALT; Grade 4 |
0
0%
|
0
0%
|
2
3.3%
|
0
0%
|
| Albumin; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Albumin; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Albumin; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Albumin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| ALP; Grade 1 |
0
0%
|
1
1.7%
|
4
6.6%
|
3
4.8%
|
| ALP; Grade 2 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| ALP; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| ALP; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| AST; Grade 1 |
6
10%
|
8
13.3%
|
7
11.5%
|
6
9.7%
|
| AST; Grade 2 |
2
3.3%
|
5
8.3%
|
1
1.6%
|
1
1.6%
|
| AST; Grade 3 |
1
1.7%
|
0
0%
|
3
4.9%
|
2
3.2%
|
| AST; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CO2/bicarbonate; Grade 1 |
1
1.7%
|
5
8.3%
|
1
1.6%
|
6
9.7%
|
| CO2/bicarbonate; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CO2/bicarbonate; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CO2/bicarbonate; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Chloride; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Chloride; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Chloride; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Chloride; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Cholesterol; Grade 1 |
7
11.7%
|
8
13.3%
|
12
19.7%
|
4
6.5%
|
| Cholesterol; Grade 2 |
3
5%
|
2
3.3%
|
3
4.9%
|
9
14.5%
|
| Cholesterol; Grade 3 |
0
0%
|
0
0%
|
2
3.3%
|
6
9.7%
|
| Cholesterol; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| CK; Grade 1 |
7
11.7%
|
5
8.3%
|
6
9.8%
|
4
6.5%
|
| CK; Grade 2 |
2
3.3%
|
2
3.3%
|
3
4.9%
|
1
1.6%
|
| CK; Grade 3 |
3
5%
|
1
1.7%
|
1
1.6%
|
2
3.2%
|
| CK; Grade 4 |
2
3.3%
|
4
6.7%
|
2
3.3%
|
4
6.5%
|
| Creatinine; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| Creatinine; Grade 2 |
1
1.7%
|
0
0%
|
0
0%
|
1
1.6%
|
| Creatinine; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Creatinine; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Glucose; Grade 1 |
10
16.7%
|
8
13.3%
|
13
21.3%
|
6
9.7%
|
| Glucose; Grade 2 |
5
8.3%
|
3
5%
|
1
1.6%
|
5
8.1%
|
| Glucose; Grade 3 |
0
0%
|
0
0%
|
2
3.3%
|
0
0%
|
| Glucose; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| HDL cholesterol; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| HDL cholesterol; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| HDL cholesterol; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| HDL cholesterol; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| LDL cholesterol; Grade 1 |
5
8.3%
|
9
15%
|
8
13.1%
|
4
6.5%
|
| LDL cholesterol; Grade 2 |
4
6.7%
|
1
1.7%
|
5
8.2%
|
8
12.9%
|
| LDL cholesterol; Grade 3 |
0
0%
|
0
0%
|
3
4.9%
|
2
3.2%
|
| LDL cholesterol; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lipase; Grade 1 |
9
15%
|
3
5%
|
5
8.2%
|
6
9.7%
|
| Lipase; Grade 2 |
6
10%
|
1
1.7%
|
7
11.5%
|
5
8.1%
|
| Lipase; Grade 3 |
2
3.3%
|
1
1.7%
|
4
6.6%
|
1
1.6%
|
| Lipase; Grade 4 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| Inorganic phosphorus; Grade 1 |
5
8.3%
|
2
3.3%
|
7
11.5%
|
6
9.7%
|
| Inorganic phosphorus; Grade 2 |
6
10%
|
2
3.3%
|
2
3.3%
|
8
12.9%
|
| Inorganic phosphorus; Grade 3 |
1
1.7%
|
1
1.7%
|
2
3.3%
|
2
3.2%
|
| Inorganic phosphorus; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium; Grade 1 |
7
11.7%
|
1
1.7%
|
2
3.3%
|
2
3.2%
|
| Potassium; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| Potassium; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sodium; Grade 1 |
7
11.7%
|
4
6.7%
|
7
11.5%
|
8
12.9%
|
| Sodium; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| Sodium; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sodium; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Total bilirubin; Grade 1 |
0
0%
|
1
1.7%
|
4
6.6%
|
0
0%
|
| Total bilirubin; Grade 2 |
2
3.3%
|
1
1.7%
|
1
1.6%
|
0
0%
|
| Total bilirubin; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Total bilirubin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Triglycerides; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Triglycerides; Grade 2 |
0
0%
|
1
1.7%
|
3
4.9%
|
2
3.2%
|
| Triglycerides; Grade 3 |
0
0%
|
0
0%
|
1
1.6%
|
0
0%
|
| Triglycerides; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| Urea/BUN; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Urea/BUN; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Urea/BUN; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Urea/BUN; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase |
|---|---|
| Description | Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Time Frame | Up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| APTT; Grade 1 |
1
1.7%
|
0
0%
|
1
1.6%
|
3
4.8%
|
| APTT; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| APTT; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| APTT; Grade 4 |
0
0%
|
1
1.7%
|
1
1.6%
|
0
0%
|
| Basophils; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Basophils; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Basophils; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Basophils; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Eosinophils; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Eosinophils; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Eosinophils; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Eosinophils; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hematocrit; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hematocrit; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hematocrit; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hematocrit; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 2 |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| INR; Grade 1 |
0
0%
|
2
3.3%
|
0
0%
|
1
1.6%
|
| INR; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| INR; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| INR; Grade 4 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| Lymphocytes; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lymphocytes; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lymphocytes; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lymphocytes; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| MCV; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| MCV; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| MCV; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| MCV; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Monocytes; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Monocytes; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Monocytes; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Monocytes; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Platelet count; Grade 1 |
2
3.3%
|
0
0%
|
2
3.3%
|
1
1.6%
|
| Platelet count; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Platelet count; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Platelet count; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PT; Grade 1 |
0
0%
|
1
1.7%
|
0
0%
|
1
1.6%
|
| PT; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PT; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PT; Grade 4 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| RBC; Grade 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| RBC; Grade 2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| RBC; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| RBC; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Total neutrophils; Grade 1 |
8
13.3%
|
6
10%
|
8
13.1%
|
2
3.2%
|
| Total neutrophils; Grade 2 |
3
5%
|
2
3.3%
|
3
4.9%
|
2
3.2%
|
| Total neutrophils; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
1
1.6%
|
| Total neutrophils; Grade 4 |
0
0%
|
0
0%
|
1
1.6%
|
1
1.6%
|
| WBC count; Grade 1 |
0
0%
|
2
3.3%
|
2
3.3%
|
1
1.6%
|
| WBC count; Grade 2 |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
| WBC count; Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| WBC count; Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase |
|---|---|
| Description | AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. |
| Time Frame | Up to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 60 | 60 | 61 | 62 |
| Number [Percentage of participants] |
0
0%
|
2
3.3%
|
5
8.2%
|
13
21%
|
| Title | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase |
|---|---|
| Description | AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. |
| Time Frame | Week 24 to Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Maintenance Safety Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. |
| Measure Participants | 52 | 53 | 55 | 47 |
| Number [Percentage of participants] |
2
3.3%
|
4
6.7%
|
2
3.3%
|
2
3.2%
|
| Title | Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 |
|---|---|
| Description | Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data |
| Time Frame | pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Summary Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. |
| Measure Participants | 14 | 12 | 11 |
| Geometric Mean (Geometric Coefficient of Variation) [Hours*micrograms per milliliter] |
45.69
(32)
|
133.74
(32)
|
227.58
(57)
|
| Title | Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 |
|---|---|
| Description | Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| Time Frame | pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Summary Population |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. |
| Measure Participants | 14 | 12 | 11 |
| Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter] |
2.77
(33)
|
7.49
(28)
|
13.12
(44)
|
| Title | Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 |
|---|---|
| Description | Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| Time Frame | pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Summary Population. Only those participants with data available at the specified time points were analyzed. |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. |
| Measure Participants | 14 | 12 | 9 |
| Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter] |
1.45
(37)
|
4.34
(38)
|
5.83
(61)
|
| Title | AUC(0 to Tau) for Rilpivirine |
|---|---|
| Description | Data was not collected for analysis of rilpivirine PK parameters. |
| Time Frame | pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. |
| Measure Participants | 0 | 0 | 0 |
| Title | Cmax for Rilpivirine |
|---|---|
| Description | Data was not collected for analysis of rilpivirine PK parameters. |
| Time Frame | pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. |
| Measure Participants | 0 | 0 | 0 |
| Title | Ctau for Rilpivirine |
|---|---|
| Description | Data was not collected for analysis of rilpivirine PK parameters. |
| Time Frame | pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized |
| Arm/Group Title | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. |
| Measure Participants | 0 | 0 | 0 |
Adverse Events
| Time Frame | Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. | |||||||||||||||||||||||
| Arm/Group Title | GSK1265744 10 mg (Induction Phase) | GSK1265744 30 mg (Induction Phase) | GSK1265744 60 mg (Induction Phase) | Efavirenz 600 mg (Induction Phase) | GSK1265744 10 mg (Maintenance Phase) | GSK1265744 30 mg (Maintenance Phase) | GSK1265744 60 mg (Maintenance Phase) | Efavirenz 600 mg (Maintenance Phase) | GSK1265744 10 mg (Open-label Phase) | GSK1265744 30 mg (Open-label Phase) | GSK1265744 60 mg (Open-label Phase) | Efavirenz 600mg (Open-label Phase) | ||||||||||||
| Arm/Group Description | Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal. | Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal. | Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. | Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal. | Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal. | Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal. | Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. | ||||||||||||
All Cause Mortality |
||||||||||||||||||||||||
| GSK1265744 10 mg (Induction Phase) | GSK1265744 30 mg (Induction Phase) | GSK1265744 60 mg (Induction Phase) | Efavirenz 600 mg (Induction Phase) | GSK1265744 10 mg (Maintenance Phase) | GSK1265744 30 mg (Maintenance Phase) | GSK1265744 60 mg (Maintenance Phase) | Efavirenz 600 mg (Maintenance Phase) | GSK1265744 10 mg (Open-label Phase) | GSK1265744 30 mg (Open-label Phase) | GSK1265744 60 mg (Open-label Phase) | Efavirenz 600mg (Open-label Phase) | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | 0/61 (0%) | 0/62 (0%) | 0/52 (0%) | 0/53 (0%) | 0/55 (0%) | 0/47 (0%) | 0/46 (0%) | 1/47 (2.1%) | 1/51 (2%) | 0/0 (NaN) | ||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||
| GSK1265744 10 mg (Induction Phase) | GSK1265744 30 mg (Induction Phase) | GSK1265744 60 mg (Induction Phase) | Efavirenz 600 mg (Induction Phase) | GSK1265744 10 mg (Maintenance Phase) | GSK1265744 30 mg (Maintenance Phase) | GSK1265744 60 mg (Maintenance Phase) | Efavirenz 600 mg (Maintenance Phase) | GSK1265744 10 mg (Open-label Phase) | GSK1265744 30 mg (Open-label Phase) | GSK1265744 60 mg (Open-label Phase) | Efavirenz 600mg (Open-label Phase) | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/60 (3.3%) | 0/60 (0%) | 2/61 (3.3%) | 2/62 (3.2%) | 5/52 (9.6%) | 5/53 (9.4%) | 5/55 (9.1%) | 2/47 (4.3%) | 7/46 (15.2%) | 8/47 (17%) | 5/51 (9.8%) | 0/0 (NaN) | ||||||||||||
| Cardiac disorders | ||||||||||||||||||||||||
| Atrial flutter | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Atrial thrombosis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Cardiac arrest | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Myocardial infarction | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||||
| Abdominal discomfort | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Anal fistula | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Colitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Enteritis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Gastrointestinal haemorrhage | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| General disorders | ||||||||||||||||||||||||
| Chest pain | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Systemic inflammatory response syndrome | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Infections and infestations | ||||||||||||||||||||||||
| Abscess | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Abscess intestinal | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Anorectal infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Appendiceal abscess | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Appendicitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Arthritis bacterial | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Cellulitis | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Osteomyelitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Pneumonia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Pyelonephritis | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Sepsis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Shigella infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Staphylococcal infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Viral infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Humerus fracture | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Investigations | ||||||||||||||||||||||||
| Liver function test increased | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
| Musculoskeletal pain | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||
| Burkitt's lymphoma | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Nervous system disorders | ||||||||||||||||||||||||
| Headache | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Seizure | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||||
| Bipolar disorder | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Depression | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Major depression | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Mania | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Substance-induced psychotic disorder | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Suicidal ideation | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Suicide attempt | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/62 (1.6%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||||||
| Nephrolithiasis | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||||||||||
| Adnexa uteri mass | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
| Pulmonary embolism | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||
| GSK1265744 10 mg (Induction Phase) | GSK1265744 30 mg (Induction Phase) | GSK1265744 60 mg (Induction Phase) | Efavirenz 600 mg (Induction Phase) | GSK1265744 10 mg (Maintenance Phase) | GSK1265744 30 mg (Maintenance Phase) | GSK1265744 60 mg (Maintenance Phase) | Efavirenz 600 mg (Maintenance Phase) | GSK1265744 10 mg (Open-label Phase) | GSK1265744 30 mg (Open-label Phase) | GSK1265744 60 mg (Open-label Phase) | Efavirenz 600mg (Open-label Phase) | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 46/60 (76.7%) | 47/60 (78.3%) | 50/61 (82%) | 54/62 (87.1%) | 35/52 (67.3%) | 44/53 (83%) | 47/55 (85.5%) | 33/47 (70.2%) | 32/46 (69.6%) | 38/47 (80.9%) | 40/51 (78.4%) | 0/0 (NaN) | ||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||
| Lymphadenopathy | 1/60 (1.7%) | 1 | 4/60 (6.7%) | 5 | 2/61 (3.3%) | 2 | 1/62 (1.6%) | 1 | 3/52 (5.8%) | 3 | 1/53 (1.9%) | 1 | 4/55 (7.3%) | 4 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Cardiac disorders | ||||||||||||||||||||||||
| Palpitations | 1/60 (1.7%) | 1 | 2/60 (3.3%) | 2 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Congenital, familial and genetic disorders | ||||||||||||||||||||||||
| Type V hyperlipidaemia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Endocrine disorders | ||||||||||||||||||||||||
| Hypogonadism | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||||
| Abdominal discomfort | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 | 1/61 (1.6%) | 1 | 3/62 (4.8%) | 3 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Abdominal pain | 5/60 (8.3%) | 5 | 4/60 (6.7%) | 4 | 4/61 (6.6%) | 4 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 2 | 0/55 (0%) | 0 | 1/47 (2.1%) | 1 | 2/46 (4.3%) | 3 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Abdominal pain lower | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Abdominal pain upper | 0/60 (0%) | 0 | 2/60 (3.3%) | 2 | 0/61 (0%) | 0 | 1/62 (1.6%) | 1 | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 1/47 (2.1%) | 1 | 1/46 (2.2%) | 1 | 3/47 (6.4%) | 4 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Anal fissure | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Anal fistula | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 2/53 (3.8%) | 3 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Anogenital dysplasia | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 | 1/61 (1.6%) | 1 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Aphthous ulcer | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 2/53 (3.8%) | 3 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Colitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Constipation | 2/60 (3.3%) | 2 | 1/60 (1.7%) | 1 | 3/61 (4.9%) | 3 | 1/62 (1.6%) | 1 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 1/47 (2.1%) | 1 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Dental caries | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Diarrhoea | 10/60 (16.7%) | 10 | 7/60 (11.7%) | 7 | 11/61 (18%) | 13 | 8/62 (12.9%) | 8 | 5/52 (9.6%) | 7 | 7/53 (13.2%) | 9 | 5/55 (9.1%) | 6 | 5/47 (10.6%) | 5 | 6/46 (13%) | 7 | 5/47 (10.6%) | 6 | 5/51 (9.8%) | 5 | 0/0 (NaN) | 0 |
| Dry mouth | 0/60 (0%) | 0 | 3/60 (5%) | 3 | 1/61 (1.6%) | 1 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Dyspepsia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 3/61 (4.9%) | 3 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 2/47 (4.3%) | 2 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Flatulence | 2/60 (3.3%) | 2 | 2/60 (3.3%) | 2 | 2/61 (3.3%) | 2 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Food poisoning | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 1/47 (2.1%) | 1 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Gastritis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Gastrooesophageal reflux disease | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 3/53 (5.7%) | 3 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 1/47 (2.1%) | 1 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Haemorrhoids | 4/60 (6.7%) | 4 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 3/62 (4.8%) | 3 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 1 | 4/46 (8.7%) | 4 | 2/47 (4.3%) | 2 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Irritable bowel syndrome | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Nausea | 14/60 (23.3%) | 15 | 11/60 (18.3%) | 14 | 11/61 (18%) | 13 | 13/62 (21%) | 13 | 0/52 (0%) | 0 | 3/53 (5.7%) | 3 | 8/55 (14.5%) | 8 | 2/47 (4.3%) | 2 | 1/46 (2.2%) | 1 | 5/47 (10.6%) | 5 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Proctalgia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Proctitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Toothache | 2/60 (3.3%) | 2 | 2/60 (3.3%) | 2 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 2/52 (3.8%) | 2 | 2/53 (3.8%) | 2 | 1/55 (1.8%) | 1 | 1/47 (2.1%) | 1 | 2/46 (4.3%) | 2 | 2/47 (4.3%) | 2 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Vomiting | 2/60 (3.3%) | 2 | 4/60 (6.7%) | 4 | 3/61 (4.9%) | 3 | 3/62 (4.8%) | 3 | 1/52 (1.9%) | 1 | 4/53 (7.5%) | 4 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 3 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| General disorders | ||||||||||||||||||||||||
| Chest pain | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 4/61 (6.6%) | 4 | 2/62 (3.2%) | 2 | 1/52 (1.9%) | 2 | 2/53 (3.8%) | 2 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 3/47 (6.4%) | 7 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Fatigue | 6/60 (10%) | 7 | 5/60 (8.3%) | 8 | 7/61 (11.5%) | 8 | 10/62 (16.1%) | 10 | 4/52 (7.7%) | 4 | 5/53 (9.4%) | 5 | 3/55 (5.5%) | 3 | 3/47 (6.4%) | 3 | 3/46 (6.5%) | 3 | 5/47 (10.6%) | 5 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Feeling drunk | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Feeling hot | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Influenza like illness | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Oedema peripheral | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Pain | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 | 2/61 (3.3%) | 2 | 4/62 (6.5%) | 4 | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Pyrexia | 1/60 (1.7%) | 2 | 3/60 (5%) | 3 | 3/61 (4.9%) | 3 | 3/62 (4.8%) | 3 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 2 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Immune system disorders | ||||||||||||||||||||||||
| Seasonal allergy | 3/60 (5%) | 3 | 1/60 (1.7%) | 1 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 3/53 (5.7%) | 4 | 4/55 (7.3%) | 5 | 1/47 (2.1%) | 1 | 4/46 (8.7%) | 4 | 3/47 (6.4%) | 5 | 4/51 (7.8%) | 7 | 0/0 (NaN) | 0 |
| Infections and infestations | ||||||||||||||||||||||||
| Anal abscess | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Anal chlamydia infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 3/46 (6.5%) | 3 | 0/47 (0%) | 0 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Body tinea | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Bronchitis | 1/60 (1.7%) | 1 | 5/60 (8.3%) | 5 | 3/61 (4.9%) | 4 | 3/62 (4.8%) | 3 | 4/52 (7.7%) | 4 | 3/53 (5.7%) | 4 | 6/55 (10.9%) | 6 | 3/47 (6.4%) | 4 | 2/46 (4.3%) | 3 | 3/47 (6.4%) | 3 | 4/51 (7.8%) | 5 | 0/0 (NaN) | 0 |
| Cellulitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 3/47 (6.4%) | 3 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Chlamydial infection | 1/60 (1.7%) | 1 | 1/60 (1.7%) | 1 | 1/61 (1.6%) | 1 | 2/62 (3.2%) | 3 | 2/52 (3.8%) | 2 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 3/47 (6.4%) | 5 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Conjunctivitis | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 1/55 (1.8%) | 1 | 1/47 (2.1%) | 1 | 2/46 (4.3%) | 2 | 1/47 (2.1%) | 1 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Ear infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Eye infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 3 | 0/0 (NaN) | 0 |
| Folliculitis | 2/60 (3.3%) | 2 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 2/53 (3.8%) | 3 | 3/55 (5.5%) | 3 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Gastroenteritis | 5/60 (8.3%) | 5 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 2/52 (3.8%) | 3 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Gonorrhoea | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 | 2/61 (3.3%) | 2 | 2/62 (3.2%) | 2 | 4/52 (7.7%) | 7 | 4/53 (7.5%) | 4 | 3/55 (5.5%) | 3 | 1/47 (2.1%) | 1 | 4/46 (8.7%) | 5 | 4/47 (8.5%) | 4 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Herpes simplex | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Herpes zoster | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 3/55 (5.5%) | 3 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Influenza | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 | 2/61 (3.3%) | 2 | 2/62 (3.2%) | 2 | 1/52 (1.9%) | 1 | 2/53 (3.8%) | 2 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 3/47 (6.4%) | 3 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Nasopharyngitis | 9/60 (15%) | 9 | 2/60 (3.3%) | 2 | 8/61 (13.1%) | 12 | 3/62 (4.8%) | 5 | 2/52 (3.8%) | 2 | 4/53 (7.5%) | 5 | 2/55 (3.6%) | 2 | 5/47 (10.6%) | 5 | 5/46 (10.9%) | 10 | 5/47 (10.6%) | 5 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Oral herpes | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Otitis media | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 3/55 (5.5%) | 3 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Pharyngitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 4/52 (7.7%) | 5 | 2/53 (3.8%) | 2 | 3/55 (5.5%) | 3 | 2/47 (4.3%) | 5 | 3/46 (6.5%) | 3 | 1/47 (2.1%) | 1 | 3/51 (5.9%) | 5 | 0/0 (NaN) | 0 |
| Pharyngitis streptococcal | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 2/47 (4.3%) | 3 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Pneumonia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Proctitis gonococcal | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Rhinitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Sinusitis | 3/60 (5%) | 4 | 2/60 (3.3%) | 3 | 5/61 (8.2%) | 5 | 1/62 (1.6%) | 1 | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 3/47 (6.4%) | 4 | 2/46 (4.3%) | 2 | 6/47 (12.8%) | 6 | 6/51 (11.8%) | 10 | 0/0 (NaN) | 0 |
| Skin infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Syphilis | 3/60 (5%) | 3 | 1/60 (1.7%) | 1 | 3/61 (4.9%) | 3 | 1/62 (1.6%) | 1 | 5/52 (9.6%) | 6 | 4/53 (7.5%) | 4 | 2/55 (3.6%) | 3 | 3/47 (6.4%) | 3 | 4/46 (8.7%) | 4 | 3/47 (6.4%) | 3 | 4/51 (7.8%) | 6 | 0/0 (NaN) | 0 |
| Tinea cruris | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Tinea infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Tinea pedis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Tooth abscess | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 1/55 (1.8%) | 1 | 1/47 (2.1%) | 1 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Upper respiratory tract infection | 3/60 (5%) | 3 | 8/60 (13.3%) | 8 | 9/61 (14.8%) | 10 | 9/62 (14.5%) | 11 | 9/52 (17.3%) | 11 | 14/53 (26.4%) | 16 | 12/55 (21.8%) | 14 | 5/47 (10.6%) | 7 | 3/46 (6.5%) | 3 | 15/47 (31.9%) | 28 | 14/51 (27.5%) | 18 | 0/0 (NaN) | 0 |
| Urethritis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 2 | 2/53 (3.8%) | 4 | 1/55 (1.8%) | 2 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Urethritis chlamydial | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Urethritis gonococcal | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Urinary tract infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 3/47 (6.4%) | 3 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Viral infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Viral upper respiratory tract infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 1/47 (2.1%) | 1 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Arthropod bite | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 3 | 0/0 (NaN) | 0 |
| Contusion | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Exposure to communicable disease | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Ligament sprain | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 2/53 (3.8%) | 2 | 2/55 (3.6%) | 3 | 1/47 (2.1%) | 1 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 4/51 (7.8%) | 5 | 0/0 (NaN) | 0 |
| Limb injury | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 1/47 (2.1%) | 1 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Meniscus injury | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Muscle strain | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 | 1/55 (1.8%) | 1 | 2/47 (4.3%) | 2 | 0/46 (0%) | 0 | 2/47 (4.3%) | 3 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Procedural pain | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 | 2/61 (3.3%) | 2 | 1/62 (1.6%) | 2 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 2/55 (3.6%) | 3 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 3/51 (5.9%) | 4 | 0/0 (NaN) | 0 |
| Skin laceration | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 2/47 (4.3%) | 2 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Investigations | ||||||||||||||||||||||||
| Blood creatine phosphokinase increased | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 | 1/55 (1.8%) | 2 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Lipase increased | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 3 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Weight decreased | 1/60 (1.7%) | 1 | 2/60 (3.3%) | 3 | 0/61 (0%) | 0 | 2/62 (3.2%) | 3 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||||||
| Decreased appetite | 3/60 (5%) | 3 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 3/62 (4.8%) | 3 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Hyperlipidaemia | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 2 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Vitamin D deficiency | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 1/47 (2.1%) | 1 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
| Arthralgia | 1/60 (1.7%) | 2 | 2/60 (3.3%) | 2 | 3/61 (4.9%) | 3 | 1/62 (1.6%) | 1 | 2/52 (3.8%) | 3 | 3/53 (5.7%) | 4 | 1/55 (1.8%) | 1 | 1/47 (2.1%) | 1 | 3/46 (6.5%) | 3 | 2/47 (4.3%) | 2 | 4/51 (7.8%) | 5 | 0/0 (NaN) | 0 |
| Back pain | 5/60 (8.3%) | 5 | 4/60 (6.7%) | 4 | 2/61 (3.3%) | 2 | 2/62 (3.2%) | 2 | 3/52 (5.8%) | 4 | 2/53 (3.8%) | 3 | 4/55 (7.3%) | 6 | 4/47 (8.5%) | 4 | 3/46 (6.5%) | 3 | 6/47 (12.8%) | 10 | 3/51 (5.9%) | 4 | 0/0 (NaN) | 0 |
| Flank pain | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Joint swelling | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 2/61 (3.3%) | 3 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Muscular weakness | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Musculoskeletal chest pain | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Musculoskeletal pain | 2/60 (3.3%) | 2 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 3/52 (5.8%) | 3 | 1/53 (1.9%) | 1 | 1/55 (1.8%) | 1 | 1/47 (2.1%) | 1 | 3/46 (6.5%) | 4 | 1/47 (2.1%) | 4 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Myalgia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Neck pain | 3/60 (5%) | 3 | 0/60 (0%) | 0 | 2/61 (3.3%) | 2 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Pain in extremity | 0/60 (0%) | 0 | 3/60 (5%) | 4 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 2/47 (4.3%) | 5 | 4/51 (7.8%) | 4 | 0/0 (NaN) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||
| Anogenital warts | 3/60 (5%) | 3 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 4/55 (7.3%) | 4 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Lipoma | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Seborrhoeic keratosis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Skin papilloma | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Nervous system disorders | ||||||||||||||||||||||||
| Balance disorder | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Disturbance in attention | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 4/62 (6.5%) | 4 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Dizziness | 5/60 (8.3%) | 5 | 5/60 (8.3%) | 5 | 2/61 (3.3%) | 2 | 18/62 (29%) | 19 | 2/52 (3.8%) | 2 | 2/53 (3.8%) | 2 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 3 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Headache | 13/60 (21.7%) | 14 | 13/60 (21.7%) | 17 | 13/61 (21.3%) | 14 | 7/62 (11.3%) | 8 | 2/52 (3.8%) | 3 | 3/53 (5.7%) | 3 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 4/46 (8.7%) | 4 | 3/47 (6.4%) | 4 | 2/51 (3.9%) | 5 | 0/0 (NaN) | 0 |
| Hypoaesthesia | 1/60 (1.7%) | 1 | 2/60 (3.3%) | 2 | 0/61 (0%) | 0 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Memory impairment | 2/60 (3.3%) | 2 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Paraesthesia | 2/60 (3.3%) | 2 | 2/60 (3.3%) | 2 | 2/61 (3.3%) | 4 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Somnolence | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 4/62 (6.5%) | 4 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||||
| Abnormal dreams | 1/60 (1.7%) | 1 | 5/60 (8.3%) | 5 | 3/61 (4.9%) | 3 | 15/62 (24.2%) | 15 | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 | 3/55 (5.5%) | 3 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Adjustment disorder with depressed mood | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Anxiety | 2/60 (3.3%) | 2 | 3/60 (5%) | 3 | 2/61 (3.3%) | 2 | 4/62 (6.5%) | 5 | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 | 3/55 (5.5%) | 3 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 1/47 (2.1%) | 1 | 6/51 (11.8%) | 6 | 0/0 (NaN) | 0 |
| Anxiety disorder | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 | 3/55 (5.5%) | 3 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Depression | 2/60 (3.3%) | 2 | 5/60 (8.3%) | 5 | 1/61 (1.6%) | 1 | 1/62 (1.6%) | 1 | 5/52 (9.6%) | 6 | 2/53 (3.8%) | 2 | 4/55 (7.3%) | 4 | 4/47 (8.5%) | 4 | 2/46 (4.3%) | 3 | 3/47 (6.4%) | 3 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Insomnia | 2/60 (3.3%) | 2 | 6/60 (10%) | 6 | 7/61 (11.5%) | 7 | 14/62 (22.6%) | 15 | 3/52 (5.8%) | 3 | 2/53 (3.8%) | 2 | 4/55 (7.3%) | 4 | 3/47 (6.4%) | 3 | 3/46 (6.5%) | 3 | 1/47 (2.1%) | 1 | 4/51 (7.8%) | 4 | 0/0 (NaN) | 0 |
| Libido decreased | 1/60 (1.7%) | 1 | 2/60 (3.3%) | 2 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Major depression | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Renal and urinary disorders | ||||||||||||||||||||||||
| Acute kidney injury | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Dysuria | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 | 1/55 (1.8%) | 1 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Nocturia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Pollakiuria | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Urinary retention | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||||||||||
| Cervical dysplasia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Erectile dysfunction | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 | 3/55 (5.5%) | 3 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Testicular pain | 0/60 (0%) | 0 | 2/60 (3.3%) | 2 | 1/61 (1.6%) | 1 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
| Cough | 5/60 (8.3%) | 7 | 5/60 (8.3%) | 5 | 4/61 (6.6%) | 4 | 6/62 (9.7%) | 6 | 3/52 (5.8%) | 4 | 3/53 (5.7%) | 3 | 1/55 (1.8%) | 1 | 2/47 (4.3%) | 2 | 1/46 (2.2%) | 1 | 5/47 (10.6%) | 7 | 4/51 (7.8%) | 5 | 0/0 (NaN) | 0 |
| Dyspnoea | 1/60 (1.7%) | 1 | 2/60 (3.3%) | 2 | 1/61 (1.6%) | 1 | 1/62 (1.6%) | 1 | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Nasal congestion | 2/60 (3.3%) | 2 | 1/60 (1.7%) | 1 | 2/61 (3.3%) | 4 | 3/62 (4.8%) | 4 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 2/46 (4.3%) | 2 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Oropharyngeal pain | 1/60 (1.7%) | 1 | 4/60 (6.7%) | 4 | 2/61 (3.3%) | 2 | 2/62 (3.2%) | 2 | 3/52 (5.8%) | 3 | 3/53 (5.7%) | 3 | 1/55 (1.8%) | 1 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 6/47 (12.8%) | 7 | 2/51 (3.9%) | 3 | 0/0 (NaN) | 0 |
| Rhinitis allergic | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 2/47 (4.3%) | 2 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Sinus congestion | 4/60 (6.7%) | 4 | 3/60 (5%) | 3 | 1/61 (1.6%) | 1 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 2/53 (3.8%) | 3 | 0/55 (0%) | 0 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 1/47 (2.1%) | 1 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Wheezing | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 0/47 (0%) | 0 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||
| Acne | 2/60 (3.3%) | 2 | 4/60 (6.7%) | 5 | 3/61 (4.9%) | 3 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 3/55 (5.5%) | 3 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 2/51 (3.9%) | 3 | 0/0 (NaN) | 0 |
| Dermatitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 2 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 1 | 2/46 (4.3%) | 2 | 2/47 (4.3%) | 2 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Dermatitis contact | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 | 2/61 (3.3%) | 2 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 2/55 (3.6%) | 2 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Dry skin | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Eczema | 3/60 (5%) | 3 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 2/51 (3.9%) | 2 | 0/0 (NaN) | 0 |
| Night sweats | 2/60 (3.3%) | 2 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 3/62 (4.8%) | 3 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Pruritus | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Rash | 3/60 (5%) | 5 | 2/60 (3.3%) | 2 | 3/61 (4.9%) | 3 | 8/62 (12.9%) | 8 | 1/52 (1.9%) | 1 | 6/53 (11.3%) | 7 | 2/55 (3.6%) | 3 | 0/47 (0%) | 0 | 1/46 (2.2%) | 1 | 2/47 (4.3%) | 2 | 3/51 (5.9%) | 3 | 0/0 (NaN) | 0 |
| Rash generalised | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/62 (3.2%) | 2 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Rash macular | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 3/62 (4.8%) | 5 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Seborrhoeic dermatitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 2/47 (4.3%) | 2 | 1/51 (2%) | 1 | 0/0 (NaN) | 0 |
| Urticaria | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 3/53 (5.7%) | 3 | 1/55 (1.8%) | 1 | 1/47 (2.1%) | 1 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Vascular disorders | ||||||||||||||||||||||||
| Hot flush | 2/60 (3.3%) | 2 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/62 (1.6%) | 1 | 0/52 (0%) | 0 | 0/53 (0%) | 0 | 0/55 (0%) | 0 | 0/47 (0%) | 0 | 0/46 (0%) | 0 | 0/47 (0%) | 0 | 0/51 (0%) | 0 | 0/0 (NaN) | 0 |
| Hypertension | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/62 (0%) | 0 | 0/52 (0%) | 0 | 3/53 (5.7%) | 3 | 1/55 (1.8%) | 1 | 1/47 (2.1%) | 2 | 1/46 (2.2%) | 1 | 2/47 (4.3%) | 2 | 4/51 (7.8%) | 4 | 0/0 (NaN) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | ViiV Healthcare |
| Phone | 866-435-7343 |
| GSKClinicalSupportHD@gsk.com |
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01641809
Other Study ID Numbers:
- 116482
First Posted:
Jul 17, 2012
Last Update Posted:
Jan 30, 2020
Last Verified:
Jan 1, 2020