A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
Sponsor
ViiV Healthcare (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01910402
Collaborator
GlaxoSmithKline (Industry)
499
89
2
108.3
5.6
0.1
Study Details
Study Description
Brief Summary
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
499 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women
Actual Study Start Date
:
Aug 22, 2013
Actual Primary Completion Date
:
Sep 22, 2015
Anticipated Study Completion Date
:
Aug 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DTG/ABC/3TC FDC As per the randomization schedule subjects will be administered with DTG/ABC/3TC (50mg/600mg/300mg) FDC tablet OD up to Week 48 and if continued if applicable in the Continuation Phase. DTG/ABC/3TC FDC may be administered with or without food |
Drug: Dolutegravir/abacavir/lamivudine FDC
Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg
|
| Active Comparator: ATV +RTV +TDF/FTC FDC As per the randomization schedule subjects will be administered with ATV (300mg capsule) +RTV (100mg tablet) + TDF/FTC (300mg/200mg tablet) FDC OD up to Week 48. ATV+RTV+ TDF/FTC FDC must be taken with food |
Drug: Atazanavir
Atazanavir capsule 300 mg
Drug: Ritonavir
Ritonavir tablet 100 mg
Drug: Tenofovir/emtricitabine FDC
Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 [Week 48]
Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomised participants who received at least one dose of study medication.
Secondary Outcome Measures
- Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time [Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48]
Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value.
- Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points [Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48]
Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in CD4+ Cell Count at Indicated Timepoints [Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48]
Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points [Baseline, Week 4, 12, 24, 36, 48]
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints. [Baseline, Week 4, 12, 24, 36, 48]
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Albumin at Indicated Timepoints. [Baseline, Week 4, 12, 24, 36, 48]
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points [Baseline, Week 4, 12, 24, 36, 48]
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Creatinine Clearance at Indicated Time Points [Baseline, Week 4, 12, 24, 36, 48]
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Lipase at Indicated Timepoints. [Baseline, Week 4, 12, 24, 36, 48]
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints. [Baseline, Week 4, 12, 24, 36, 48]
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points [Baseline, Week 4, 12, 24, 36, 48]
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Erythrocytes at Indicated Time Points. [Baseline, Week 4, 12, 24, 36, 48]
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Hematocrit Count at Indicated Time Points. [Baseline, Week 4, 12, 24, 36, 48]
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points. [Baseline, Week 4, 12, 24, 36, 48]
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
- Change From Baseline in Triglycerides at Week 48 [Baseline and Week 48]
Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
- Change From Baseline in TC/HDL Ratio at Week 48 [Baseline and Week 48]
Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
- Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points [Baseline, Week 24, Week 48]
Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed.
- Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table. [Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC]
Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randimization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
- Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs) [From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)]
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (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, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
- Summary of Maximum Post-Baseline Emergent Chemistry Toxicities [Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC]
Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
- Summary of Maximum Post-Baseline Emergent Hematology Toxicities [Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC]
Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
- Number of Participants Who Withdrew From Treatment Due to AEs [average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC]
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as 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, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
- Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints [Baseline, Week 24, 48]
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
- Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints [Baseline, Week 24, 48]
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
- Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 [Baseline, Weeks 24, 48]
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
- Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline [Baseline, Weeks 24, 48]
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.
- Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS [Baseline and Week 48]
The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
- Assessment of HIVTSQs Total Score at Indicated Timepoints. [Week 4, 12, 24, 48]
The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
- Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups [Week 48]
Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
- Number of Participants With Post-Baseline HIV-1 Disease Progression [Up to week 48]
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
- Number of Participants With Treatment Emergent Resistances [Up to week 48]
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
HIV-1 infected females (gender at birth) >=18 years of age
-
Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
-
HIV-1 infection as documented by Screening plasma HIV-1 RNA >=500 c/mL.
-
Documentation that the subject is negative for the HLA-B*5701 allele.
-
Antiretroviral-naïve (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).
-
Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.
Exclusion Criteria:
-
Women who are pregnant or breastfeeding
-
Women who plan to become pregnant during the first 48 weeks of the study
-
Any subject who has had a medical intervention for gender reassignment
-
Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease
-
Subjects with any degree of hepatic impairment
-
Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study
-
History or presence of allergy to the study drugs or their components or drugs of their class
-
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia
-
poses a significant suicidality risk
-
History of osteoporosis with fracture or requiring pharmacologic therapy
-
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
-
Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses;
-
Treatment with any agent, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP)
-
Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP
-
Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result
-
Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol)
-
Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound
-
Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)
-
Subject has CrCL of <50 mL/min via Cockroft-Gault method
-
Corrected QT interval (QTc (Bazett)) ≥450msec or QTc (Bazett) ≥480msec for subjects with bundle branch block.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Phoenix | Arizona | United States | 85015 |
| 2 | GSK Investigational Site | Bakersfield | California | United States | 93301 |
| 3 | GSK Investigational Site | Beverly Hills | California | United States | 90211 |
| 4 | GSK Investigational Site | Washington | District of Columbia | United States | 20007 |
| 5 | GSK Investigational Site | Fort Pierce | Florida | United States | 34982 |
| 6 | GSK Investigational Site | Miami | Florida | United States | 33133 |
| 7 | GSK Investigational Site | Orlando | Florida | United States | 32803 |
| 8 | GSK Investigational Site | Tampa | Florida | United States | 33602 |
| 9 | GSK Investigational Site | West Palm Beach | Florida | United States | 33401 |
| 10 | GSK Investigational Site | Atlanta | Georgia | United States | 30309 |
| 11 | GSK Investigational Site | Augusta | Georgia | United States | 30912-3130 |
| 12 | GSK Investigational Site | Decatur | Georgia | United States | 30033 |
| 13 | GSK Investigational Site | Savannah | Georgia | United States | 31401 |
| 14 | GSK Investigational Site | Indianapolis | Indiana | United States | 46202 |
| 15 | GSK Investigational Site | Springfield | Massachusetts | United States | 01199 |
| 16 | GSK Investigational Site | Detroit | Michigan | United States | 48202 |
| 17 | GSK Investigational Site | Kansas City | Missouri | United States | 64111 |
| 18 | GSK Investigational Site | Saint Louis | Missouri | United States | 63110 |
| 19 | GSK Investigational Site | Omaha | Nebraska | United States | 68198 |
| 20 | GSK Investigational Site | Las Vegas | Nevada | United States | 89106 |
| 21 | GSK Investigational Site | Neptune | New Jersey | United States | 7754 |
| 22 | GSK Investigational Site | Newark | New Jersey | United States | 07103 |
| 23 | GSK Investigational Site | Buffalo | New York | United States | 14215 |
| 24 | GSK Investigational Site | Valhalla | New York | United States | 10595 |
| 25 | GSK Investigational Site | Chapel Hill | North Carolina | United States | 27514 |
| 26 | GSK Investigational Site | Charlotte | North Carolina | United States | 28207 |
| 27 | GSK Investigational Site | Greensboro | North Carolina | United States | 27401-1209 |
| 28 | GSK Investigational Site | Allentown | Pennsylvania | United States | 18102 |
| 29 | GSK Investigational Site | Philadelphia | Pennsylvania | United States | 19104 |
| 30 | GSK Investigational Site | Philadelphia | Pennsylvania | United States | 19107 |
| 31 | GSK Investigational Site | Philadelphia | Pennsylvania | United States | 19140 |
| 32 | GSK Investigational Site | Bellaire | Texas | United States | 77401 |
| 33 | GSK Investigational Site | Dallas | Texas | United States | 75235 |
| 34 | GSK Investigational Site | Dallas | Texas | United States | 75246 |
| 35 | GSK Investigational Site | El Paso | Texas | United States | 79905 |
| 36 | GSK Investigational Site | Fort Worth | Texas | United States | 76104 |
| 37 | GSK Investigational Site | Lynchburg | Virginia | United States | 24501 |
| 38 | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | C1405CKC |
| 39 | GSK Investigational Site | Ciudad de Buenos Aires | Buenos Aires | Argentina | C1202ABB |
| 40 | GSK Investigational Site | Buenos Aires | Argentina | 1141 | |
| 41 | GSK Investigational Site | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 42 | GSK Investigational Site | Ottawa | Ontario | Canada | K1H 8L6 |
| 43 | GSK Investigational Site | Toronto | Ontario | Canada | M4N 3M5 |
| 44 | GSK Investigational Site | Toronto | Ontario | Canada | M5G 2N2 |
| 45 | GSK Investigational Site | Montreal | Quebec | Canada | H2X 2P4 |
| 46 | GSK Investigational Site | Bobigny | France | 93009 | |
| 47 | GSK Investigational Site | Nantes | France | 44093 | |
| 48 | GSK Investigational Site | Paris Cedex 10 | France | 75475 | |
| 49 | GSK Investigational Site | Genova | Liguria | Italy | 16128 |
| 50 | GSK Investigational Site | Bergamo | Lombardia | Italy | 24127 |
| 51 | GSK Investigational Site | Brescia | Lombardia | Italy | 25123 |
| 52 | GSK Investigational Site | Busto Arsizio (VA) | Lombardia | Italy | 21052 |
| 53 | GSK Investigational Site | Milano | Lombardia | Italy | 20127 |
| 54 | GSK Investigational Site | Milano | Lombardia | Italy | 20157 |
| 55 | GSK Investigational Site | Torino | Piemonte | Italy | 10149 |
| 56 | GSK Investigational Site | Guadalajara | Jalisco | Mexico | 44280 |
| 57 | GSK Investigational Site | Mexico | Mexico | 14000 | |
| 58 | GSK Investigational Site | Amadora | Portugal | 2720-276 | |
| 59 | GSK Investigational Site | Lisboa | Portugal | 1150 | |
| 60 | GSK Investigational Site | Porto | Portugal | 4200-319 | |
| 61 | GSK Investigational Site | Ponce | Puerto Rico | 00717 | |
| 62 | GSK Investigational Site | San Juan | Puerto Rico | 00909 | |
| 63 | GSK Investigational Site | Moscow | Russian Federation | 115035 | |
| 64 | GSK Investigational Site | Orel | Russian Federation | 302040 | |
| 65 | GSK Investigational Site | Smolensk | Russian Federation | 214006 | |
| 66 | GSK Investigational Site | St. Petersburg | Russian Federation | 190103 | |
| 67 | GSK Investigational Site | St. Petersburg | Russian Federation | 196645 | |
| 68 | GSK Investigational Site | Toliyatti | Russian Federation | 445846 | |
| 69 | GSK Investigational Site | Observatory, Cape Town | Western Province | South Africa | 7925 |
| 70 | GSK Investigational Site | Mamelodi East | South Africa | 122 | |
| 71 | GSK Investigational Site | (Móstoles) Madrid | Spain | 28935 | |
| 72 | GSK Investigational Site | Alicante | Spain | 03010 | |
| 73 | GSK Investigational Site | Badalona | Spain | 08916 | |
| 74 | GSK Investigational Site | Barcelona | Spain | 08035 | |
| 75 | GSK Investigational Site | Barcelona | Spain | 08907 | |
| 76 | GSK Investigational Site | Granada | Spain | 18012 | |
| 77 | GSK Investigational Site | Madrid | Spain | 28034 | |
| 78 | GSK Investigational Site | Madrid | Spain | 28046 | |
| 79 | GSK Investigational Site | Malaga | Spain | 29010 | |
| 80 | GSK Investigational Site | Murcia | Spain | 30003 | |
| 81 | GSK Investigational Site | Sevilla | Spain | 41013 | |
| 82 | GSK Investigational Site | Bangkok | Thailand | 10330 | |
| 83 | GSK Investigational Site | Nonthaburi | Thailand | 11000 | |
| 84 | GSK Investigational Site | Birmingham | United Kingdom | B9 5SS | |
| 85 | GSK Investigational Site | London | United Kingdom | E1 1BB | |
| 86 | GSK Investigational Site | London | United Kingdom | NW3 2QG | |
| 87 | GSK Investigational Site | London | United Kingdom | W2 1NY | |
| 88 | GSK Investigational Site | Sheffield | United Kingdom | S10 2JF | |
| 89 | GSK Investigational Site | Tooting, London | United Kingdom | SW17 0QT |
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:
NCT01910402
Other Study ID Numbers:
- 117172
- 2012-005823-34
First Posted:
Jul 29, 2013
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ViiV Healthcare
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study. |
|---|---|
| Pre-assignment Detail | A total of 499 participants were randomized to receive dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC) fixed dose combination (FDC) or combination of atazanavir (ATV), Ritonavir (RTV) and FDC of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). A total of 495 participants received at least single dose of investigational products (IP). |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Period Title: Randomized Phase | ||
| STARTED | 248 | 247 |
| COMPLETED | 206 | 192 |
| NOT COMPLETED | 42 | 55 |
| Period Title: Randomized Phase | ||
| STARTED | 120 | 0 |
| COMPLETED | 30 | 0 |
| NOT COMPLETED | 90 | 0 |
Baseline Characteristics
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD | Total |
|---|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. | Total of all reporting groups |
| Overall Participants | 248 | 247 | 495 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
38.1
(11.15)
|
37.8
(10.14)
|
37.9
(10.65)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
248
100%
|
247
100%
|
495
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| African American/African Heritage |
102
41.1%
|
108
43.7%
|
210
42.4%
|
| American Indian Or Alaskan Native |
6
2.4%
|
7
2.8%
|
13
2.6%
|
| Asian - Central/South Asian Heritage |
2
0.8%
|
0
0%
|
2
0.4%
|
| Asian - East Asian Heritage |
0
0%
|
1
0.4%
|
1
0.2%
|
| Asian - South East Asian Heritage |
20
8.1%
|
22
8.9%
|
42
8.5%
|
| Native Hawaiian Or Other Pacific Islander |
1
0.4%
|
0
0%
|
1
0.2%
|
| White - Arabic/North African Heritage |
3
1.2%
|
3
1.2%
|
6
1.2%
|
| White - White/Caucasian/European Heritage |
112
45.2%
|
104
42.1%
|
216
43.6%
|
| Mixed Race |
2
0.8%
|
2
0.8%
|
4
0.8%
|
Outcome Measures
| Title | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 |
|---|---|
| Description | Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomised participants who received at least one dose of study medication. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Number [Percentage of participants] |
82
33.1%
|
71
28.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
| Comments | Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12% | |
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted difference in proportion |
| Estimated Value | 10.5 | |
| Confidence Interval |
(2-Sided) 95% 3.1 to 17.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time |
|---|---|
| Description | Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. |
| Time Frame | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it wasi) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| HIV-1 RNA <50 c/mL, Baseline |
0
0%
|
0
0%
|
| HIV-1 RNA <50 c/mL, Week 4 |
64
25.8%
|
13
5.3%
|
| HIV-1 RNA <50 c/mL, Week 12 |
81
32.7%
|
49
19.8%
|
| HIV-1 RNA <50 c/mL, Week 24 |
85
34.3%
|
77
31.2%
|
| HIV-1 RNA <50 c/mL, Week 36 |
85
34.3%
|
77
31.2%
|
| HIV-1 RNA <50 c/mL, Week 48 |
82
33.1%
|
71
28.7%
|
| HIV-1 RNA <400 c/mL, Baseline |
0.8
0.3%
|
0.8
0.3%
|
| HIV-1 RNA <400 c/mL, Week 4 |
90
36.3%
|
54
21.9%
|
| HIV-1 RNA <400 c/mL, Week 12 |
91
36.7%
|
84
34%
|
| HIV-1 RNA <400 c/mL, Week 24 |
88
35.5%
|
82
33.2%
|
| HIV-1 RNA <400 c/mL, Week 36 |
86
34.7%
|
81
32.8%
|
| HIV-1 RNA <400 c/mL, Week 48 |
83
33.5%
|
76
30.8%
|
| Title | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points |
|---|---|
| Description | Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n=248, 247 |
4.481
(0.8111)
|
4.441
(0.8023)
|
| Week 4, n=245, 238 |
-2.646
(0.7971)
|
-1.932
(0.5303)
|
| Week 12, n=236, 226 |
-2.831
(0.8945)
|
-2.585
(0.7321)
|
| Week 24, n=225, 212 |
-2.868
(0.9196)
|
-2.801
(0.8920)
|
| Week 36, n=221, 204 |
-2.922
(0.8611)
|
-2.851
(0.8470)
|
| Week 48, n=207, 192 |
-2.960
(0.8033)
|
-2.834
(0.8462)
|
| Title | Change From Baseline in CD4+ Cell Count at Indicated Timepoints |
|---|---|
| Description | Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n=248, 247 |
369.7
(225.67)
|
380.3
(223.60)
|
| Week 4, n=245, 237 |
94.9
(140.02)
|
73.7
(108.15)
|
| Week 12, n=236, 224 |
143.8
(142.19)
|
124.4
(133.60)
|
| Week 24, n=226, 210 |
200.6
(162.37)
|
163.0
(126.67)
|
| Week 36, n=219, 204 |
230.7
(163.61)
|
191.4
(167.24)
|
| Week 48, n=208, 191 |
248.8
(172.01)
|
230.7
(189.59)
|
| Title | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points |
|---|---|
| Description | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. A value of "99999" indicates where no data is available or not able to determine the value. |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Carbon Dioxide, Baseline, n= 248, 247 |
22.1
(2.37)
|
21.5
(2.28)
|
| Carbon Dioxide, Week 4, n= 244, 237 |
-0.4
(2.29)
|
0.6
(2.2)
|
| Carbon Dioxide, Week 12, n= 236, 226 |
-0.2
(2.2)
|
0.8
(2.19)
|
| Carbon Dioxide, Week 24, n= 224, 212 |
-0.5
(2.31)
|
0.3
(2.38)
|
| Carbon Dioxide, Week 36, n= 219, 204 |
0
(2.34)
|
0.6
(2.5)
|
| Carbon Dioxide, Week 48, n= 208, 192 |
-0.6
(2.55)
|
0.4
(2.46)
|
| Chloride, Baseline, n= 248, 247 |
104
(2.49)
|
104.6
(2.63)
|
| Chloride, Week 4, n= 245, 237 |
0.6
(2.42)
|
-0.5
(2.68)
|
| Chloride, Week 12, n= 236, 226 |
1
(2.51)
|
0.2
(2.58)
|
| Chloride, Week 24, n= 225, 212 |
0.7
(2.71)
|
-0.1
(2.58)
|
| Chloride, Week 36, n= 219, 204 |
0.9
(2.65)
|
0
(2.96)
|
| Chloride, Week 48, n= 208, 192 |
0.7
(2.42)
|
0
(2.63)
|
| CHLS, Baseline, n= 230, 232 |
4.351
(0.9389)
|
4.324
(0.9766)
|
| CHLS, Week 4, n= 1, 3 |
-0.1
(99999)
|
-0.017
(0.446)
|
| CHLS, Week 12, n= 224, 221 |
0.298
(0.7492)
|
-0.058
(0.7137)
|
| CHLS, Week 24, n= 218, 201 |
0.317
(0.7254)
|
-0.001
(0.7456)
|
| CHLS, Week 36, n= 205, 191 |
0.33
(0.7328)
|
0
(0.7509)
|
| CHLS, Week 48, n= 195, 175 |
0.447
(0.7441)
|
0.109
(0.7647)
|
| Glucose, Baseline, n= 231, 234 |
4.91
(1.003)
|
4.88
(1.41)
|
| Glucose, Week 12, n= 226, 224 |
0.3
(1.359)
|
0.22
(1.234)
|
| Glucose, Week 24, n= 219, 204 |
0.17
(0.811)
|
0.26
(1.248)
|
| Glucose, Week 36, n= 211, 196 |
0.17
(1.24)
|
0.34
(1.753)
|
| Glucose, Week 48, n= 197, 180 |
0.18
(1.01)
|
0.24
(1.377)
|
| HDL CHLS, Direct, Baseline, n= 230, 232 |
1.23
(0.3717)
|
1.235
(0.3953)
|
| HDL CHLS, Direct, Week 4, n= 1, 3 |
-0.1
(99999)
|
0
(0.0529)
|
| HDL CHLS, Direct, Week 12, n= 224, 221 |
0.182
(0.3407)
|
0.005
(0.2316)
|
| HDL CHLS, Direct, Week 24, n= 218, 201 |
0.201
(0.2962)
|
0.053
(0.2819)
|
| HDL CHLS, Direct, Week 36, n= 205, 191 |
0.204
(0.2943)
|
0.036
(0.2848)
|
| HDL CHLS, Direct, Week 48, n= 195, 175 |
0.231
(0.2911)
|
0.081
(0.2964)
|
| Hyperglycaemia, Baseline, n= 231, 234 |
4.91
(1.003)
|
4.88
(1.41)
|
| Hyperglycaemia, Week 12, n= 226, 224 |
0.3
(1.359)
|
0.22
(1.234)
|
| Hyperglycaemia, Week 24, n= 219, 204 |
0.17
(0.811)
|
0.26
(1.248)
|
| Hyperglycaemia, Week 36, n= 211, 196 |
0.17
(1.24)
|
0.34
(1.753)
|
| Hyperglycaemia, Week 48, n= 197, 180 |
0.18
(1.01)
|
0.24
(1.377)
|
| Hyperkalemia, Baseline, n= 248, 247 |
4.11
(0.304)
|
4.08
(0.33)
|
| Hyperkalemia, Week 4, n= 244, 237 |
-0.01
(0.344)
|
0.12
(0.367)
|
| Hyperkalemia, Week 12, n= 236, 226 |
0.03
(0.355)
|
0.1
(0.39)
|
| Hyperkalemia, Week 24, n= 224, 212 |
-0.04
(0.339)
|
0.06
(0.372)
|
| Hyperkalemia, Week 36, n= 219, 204 |
0.03
(0.332)
|
0.13
(0.387)
|
| Hyperkalemia, Week 48, n= 208, 192 |
-0.04
(0.346)
|
0.04
(0.372)
|
| Hypernatremia, Baseline, n= 248, 247 |
137.6
(2.25)
|
137.8
(2.48)
|
| Hypernatremia, Week 4, n= 245, 237 |
0
(2.11)
|
-0.5
(2.4)
|
| Hypernatremia, Week 12, n= 236, 226 |
0.7
(2.3)
|
0.1
(2.51)
|
| Hypernatremia, Week 24, n= 225, 212 |
0.6
(2.3)
|
0.2
(2.11)
|
| Hypernatremia, Week 36, n= 219, 204 |
0.9
(2.32)
|
0.2
(2.5)
|
| Hypernatremia, Week 48, n= 208, 192 |
0.6
(2.24)
|
0.5
(2.39)
|
| Hypoglycaemia, Baseline, n= 231, 234 |
4.91
(1.003)
|
4.88
(1.41)
|
| Hypoglycaemia, Week 12, n= 226, 224 |
0.3
(1.359)
|
0.22
(1.234)
|
| Hypoglycaemia, Week 24, n= 219, 204 |
0.17
(0.811)
|
0.26
(1.248)
|
| Hypoglycaemia, Week 36, n= 211, 196 |
0.17
(1.24)
|
0.34
(1.753)
|
| Hypoglycaemia, Week 48, n= 197, 180 |
0.18
(1.01)
|
0.24
(1.377)
|
| Hypokalemia, Baseline, n= 248, 247 |
4.11
(0.304)
|
4.08
(0.33)
|
| Hypokalemia, Week 4, n= 244, 237 |
-0.01
(0.344)
|
0.12
(0.367)
|
| Hypokalemia, Week 12, n= 236, 226 |
0.03
(0.355)
|
0.1
(0.39)
|
| Hypokalemia, Week 24, n= 224, 212 |
-0.04
(0.339)
|
0.06
(0.372)
|
| Hypokalemia, Week 36, n= 219, 204 |
0.03
(0.332)
|
0.13
(0.387)
|
| Hypokalemia, Week 48, n= 208, 192 |
-0.04
(0.346)
|
0.04
(0.372)
|
| Hyponatremia, Baseline, n= 248, 247 |
137.6
(2.25)
|
137.8
(2.48)
|
| Hyponatremia, Week 4, n= 245, 237 |
0
(2.11)
|
-0.5
(2.4)
|
| Hyponatremia, Week 12, n= 236, 226 |
0.7
(2.3)
|
0.1
(2.51)
|
| Hyponatremia, Week 24, n= 225, 212 |
0.6
(2.3)
|
0.2
(2.11)
|
| Hyponatremia, Week 36, n= 219, 204 |
0.9
(2.32)
|
0.2
(2.5)
|
| Hyponatremia, Week 48, n= 208, 192 |
0.6
(2.24)
|
0.5
(2.39)
|
| LDL CHLS Calculation, Baseline, n= 229, 231 |
2.513
(0.7912)
|
2.537
(0.8016)
|
| LDL CHLS Calculation, Week 4, n= 1, 3 |
0.08
(99999)
|
-0.123
(0.5255)
|
| LDL CHLS Calculation, Week 12, n= 221, 219 |
0.125
(0.6045)
|
-0.14
(0.6114)
|
| LDL CHLS Calculation, Week 24, n= 213, 201 |
0.111
(0.6209)
|
-0.111
(0.6188)
|
| LDL CHLS Calculation, Week 36, n= 201, 188 |
0.112
(0.6385)
|
-0.099
(0.6049)
|
| LDL CHLS Calculation, Week 48, n= 190, 175 |
0.213
(0.6499)
|
-0.021
(0.6227)
|
| LDL CHLS, Direct, Baseline, n= 13, 7 |
2.522
(0.7586)
|
2.993
(0.7707)
|
| LDL CHLS, Direct, Week 12, n= 0, 1 |
99999
(99999)
|
-0.44
(99999)
|
| LDL CHLS, Direct, Week 24, n= 1, 0 |
-0.64
(99999)
|
99999
(99999)
|
| LDL CHLS, Direct, Week 36, n= 1, 0 |
-0.23
(99999)
|
99999
(99999)
|
| LDL CHLS, Direct, Week 48, n= 0 |
99999
(99999)
|
99999
(99999)
|
| Phosphate, Baseline, n= 248, 247 |
1.15
(0.1695)
|
1.142
(0.1732)
|
| Phosphate, Week 4, n= 245, 237 |
0
(0.1461)
|
-0.032
(0.1726)
|
| Phosphate, Week 12, n= 236, 226 |
0.02
(0.1694)
|
0.026
(0.1634)
|
| Phosphate, Week 24, n= 225, 212 |
0.021
(0.1628)
|
0.026
(0.1701)
|
| Phosphate, Week 36, n= 219, 204 |
0.029
(0.1736)
|
0.009
(0.1675)
|
| Phosphate, Week 48, n= 208, 192 |
0.016
(0.1736)
|
0
(0.1673)
|
| Potassium, Baseline, n= 248, 247 |
4.11
(0.304)
|
4.08
(0.33)
|
| Potassium, Week 4, n= 244, 237 |
-0.01
(0.344)
|
0.12
(0.367)
|
| Potassium, Week 12, n= 236, 226 |
0.03
(0.355)
|
0.1
(0.39)
|
| Potassium, Week 24, n= 224, 212 |
-0.04
(0.339)
|
0.06
(0.372)
|
| Potassium, Week 36, n= 219, 204 |
0.03
(0.332)
|
0.13
(0.387)
|
| Potassium, Week 48, n= 208, 192 |
-0.04
(0.346)
|
0.04
(0.372)
|
| Sodium, Baseline, n= 248, 247 |
137.6
(2.25)
|
137.8
(2.48)
|
| Sodium, Week 4, n= 245, 237 |
0
(2.11)
|
-0.5
(2.4)
|
| Sodium, Week 12, n= 236, 226 |
0.7
(2.3)
|
0.1
(2.51)
|
| Sodium, Week 24, n= 225, 212 |
0.6
(2.3)
|
0.2
(2.11)
|
| Sodium, Week 36, n= 219, 204 |
0.9
(2.32)
|
0.2
(2.5)
|
| Sodium, Week 48, n= 208, 192 |
0.6
(2.24)
|
0.5
(2.39)
|
| Triglycerides, Baseline, n= 230, 232 |
1.335
(0.8261)
|
1.217
(0.6642)
|
| Triglycerides, Week 4, n= 1, 3 |
-0.18
(99999)
|
0.237
(0.2491)
|
| Triglycerides, Week 12, n= 224, 221 |
-0.04
(0.6861)
|
0.167
(0.7074)
|
| Triglycerides, Week 24, n= 218, 201 |
0.036
(0.7108)
|
0.125
(0.6132)
|
| Triglycerides, Week 36, n= 205, 191 |
0.037
(0.6732)
|
0.157
(0.6785)
|
| Triglycerides, Week 48, n= 195, 175 |
0.018
(0.8158)
|
0.107
(0.5527)
|
| Urea, Baseline, n= 248, 247 |
4.28
(1.329)
|
4.43
(1.518)
|
| Urea, Week 4, n= 245, 237 |
-0.04
(1.085)
|
0.1
(1.313)
|
| Urea, Week 12, n= 236, 226 |
0.08
(1.097)
|
0.16
(1.409)
|
| Urea, Week 24, n= 225, 212 |
0.03
(1.187)
|
0.12
(1.283)
|
| Urea, Week 36, n= 219, 204 |
0.08
(1.236)
|
-0.03
(1.256)
|
| Urea, Week 48, n= 208, 192 |
0.1
(1.162)
|
0.02
(1.179)
|
| Title | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints. |
|---|---|
| Description | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Bilirubin, Baseline, n= 248, 247 |
7.4
(3.2)
|
7.5
(3.11)
|
| Bilirubin, Week 4, n= 244, 237 |
-0.8
(2.59)
|
27.2
(23.15)
|
| Bilirubin, Week 12, n= 236, 226 |
-0.6
(2.65)
|
22.8
(16.49)
|
| Bilirubin, Week 24, n= 225, 212 |
-0.2
(3.06)
|
25
(18.38)
|
| Bilirubin, Week 36, n= 219, 204 |
-0.2
(3.01)
|
23.8
(16.31)
|
| Bilirubin, Week 48, n= 208, 192 |
-0.3
(3.08)
|
23.7
(17)
|
| Creatinine, Baseline, n= 248, 247 |
58.29
(12.035)
|
61.56
(15.43)
|
| Creatinine, Week 4, n= 245, 237 |
8.4
(7.057)
|
4.89
(7.109)
|
| Creatinine, Week 12, n= 236, 226 |
9.2
(8.288)
|
5.83
(8.357)
|
| Creatinine, Week 24, n= 225, 212 |
9.16
(9.983)
|
5.8
(8.063)
|
| Creatinine, Week 36, n= 219, 204 |
10.08
(10.473)
|
5.37
(9.013)
|
| Creatinine, Week 48, n= 208, 192 |
9.29
(8.614)
|
5.86
(10.252)
|
| Title | Change From Baseline in Albumin at Indicated Timepoints. |
|---|---|
| Description | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n= 248, 247 |
41.3
(4.39)
|
41.5
(3.88)
|
| Week 4, n= 245, 237 |
0.1
(2.36)
|
-0.5
(2.59)
|
| Week 12, n= 236, 226 |
0.5
(2.95)
|
0.1
(2.59)
|
| Week 24, n= 225, 212 |
1.4
(3.2)
|
0.8
(2.95)
|
| Week 36, n= 219, 204 |
1.4
(3.09)
|
0.6
(2.96)
|
| Week 48, n= 208, 192 |
1.7
(3.17)
|
1.3
(3.04)
|
| Title | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points |
|---|---|
| Description | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Alanine aminotransferase, Baseline, n= 248, 247 |
22.5
(26.69)
|
22.3
(20.47)
|
| Alanine aminotransferase, Week 4, n= 245, 237 |
-3.3
(27.54)
|
-3.4
(15.86)
|
| Alanine aminotransferase, Week 12, n= 236, 226 |
-5.2
(27.51)
|
-2.3
(20.26)
|
| Alanine aminotransferase, Week 24, n= 225, 212 |
-5.4
(27.92)
|
-3.7
(20.7)
|
| Alanine aminotransferase, Week 36, n= 219, 204 |
-4.9
(36.11)
|
-5.3
(20.08)
|
| Alanine aminotransferase, Week 48, n= 208, 192 |
-5.7
(28.54)
|
-1.5
(31.53)
|
| Alkaline phosphatase, Baseline, n= 248, 247 |
72.7
(22.75)
|
72
(30.26)
|
| Alkaline phosphatase, Week 4, n= 245, 237 |
-1.5
(14.56)
|
9.4
(28.69)
|
| Alkaline phosphatase, Week 12, n= 236, 226 |
-2.1
(17.1)
|
15.1
(30.82)
|
| Alkaline phosphatase, Week 24, n= 225, 212 |
0.5
(17.86)
|
22.4
(41.59)
|
| Alkaline phosphatase, Week 36, n= 219, 204 |
0.6
(19.19)
|
20.4
(30.7)
|
| Alkaline phosphatase, Week 48, n= 208, 192 |
2.9
(28.05)
|
21.9
(25.35)
|
| Aspartate aminotransferase, Baseline, n= 248, 247 |
28.7
(22.11)
|
28.3
(19.77)
|
| Aspartate aminotransferase, Week 4, n= 244, 237 |
-3.3
(29.8)
|
-3.6
(18.83)
|
| Aspartate aminotransferase, Week 12, n= 236, 226 |
-6.2
(21.11)
|
-4
(13.79)
|
| Aspartate aminotransferase, Week 24, n= 224, 212 |
-6.3
(22.44)
|
-5.1
(13.8)
|
| Aspartate aminotransferase, Week 36, n= 219, 204 |
-6.4
(31.42)
|
-6.5
(16.63)
|
| Aspartate aminotransferase, Week 48, n= 208, 192 |
-7.5
(22.19)
|
-3.7
(25.28)
|
| Creatine Kinase, Baseline, n= 248, 247 |
97.4
(88.55)
|
105.5
(100.51)
|
| Creatine Kinase, Week 4, n= 245, 237 |
-0.3
(68.72)
|
35.6
(549.1)
|
| Creatine Kinase, Week 12, n= 236, 226 |
6.9
(73.7)
|
7.3
(90.39)
|
| Creatine Kinase, Week 24, n= 225, 212 |
10.3
(88.66)
|
5.8
(77.12)
|
| Creatine Kinase, Week 36, n= 219, 204 |
11.9
(155.68)
|
7.2
(132.74)
|
| Creatine Kinase, Week 48, n= 208, 192 |
23.8
(242.66)
|
3.8
(98.58)
|
| Title | Change From Baseline in Creatinine Clearance at Indicated Time Points |
|---|---|
| Description | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n= 248, 247 |
132.1
(42.95)
|
128.7
(45.96)
|
| Week 4, n= 245, 237 |
-16.3
(15.03)
|
-7.5
(12.91)
|
| Week 12, n= 236, 226 |
-17.3
(17.01)
|
-7
(23.14)
|
| Week 24, n= 225, 212 |
-16.2
(20.36)
|
-9.1
(16.88)
|
| Week 36, n= 219, 204 |
-16.8
(22.35)
|
-7.5
(17.67)
|
| Week 48, n= 208, 192 |
-15.9
(19.62)
|
-7.7
(18.42)
|
| Title | Change From Baseline in Lipase at Indicated Timepoints. |
|---|---|
| Description | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n= 248, 247 |
32.9
(24.67)
|
32.3
(22.14)
|
| Week 4, n= 245, 237 |
-1.2
(15.06)
|
-1.3
(15.81)
|
| Week 12, n= 236, 226 |
-2.2
(22.74)
|
-2.1
(29)
|
| Week 24, n= 225, 212 |
-6
(21.05)
|
-6
(18.57)
|
| Week 36, n= 219, 204 |
-6.3
(25.62)
|
-6.3
(21.36)
|
| Week 48, n= 208, 192 |
-6.5
(29.63)
|
-7.8
(20.72)
|
| Title | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints. |
|---|---|
| Description | Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n= 247, 245 |
3.78841
(1.33327)
|
3.84622
(2.6556)
|
| Week 4, n= 1, 4 |
0.1264
(99999)
|
0.21588
(0.60727)
|
| Week 12, n= 233, 223 |
-0.2736
(1.0283)
|
-0.1092
(0.73776)
|
| Week 24, n= 224, 209 |
-0.3098
(1.11093)
|
-0.1922
(0.79848)
|
| Week 36, n= 212, 198 |
-0.3286
(1.01181)
|
-0.1433
(0.79498)
|
| Week 48, n= 207, 186 |
-0.2886
(1.01415)
|
-0.1444
(1.23362)
|
| Title | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points |
|---|---|
| Description | Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Basophils, Baseline, n= 248, 247 |
0.017
(0.0139)
|
0.017
(0.0127)
|
| Basophils, Week 4, n= 241, 234 |
0.003
(0.0182)
|
0.003
(0.0198)
|
| Basophils, Week 12, n= 228, 216 |
0.002
(0.0174)
|
0.003
(0.0162)
|
| Basophils, Week 24, n= 221, 208 |
0.004
(0.0187)
|
0.003
(0.0155)
|
| Basophils, Week 36, n= 214, 203 |
0.004
(0.0182)
|
0.003
(0.0158)
|
| Basophils, Week 48, n= 206, 189 |
0.005
(0.0199)
|
0.006
(0.0146)
|
| Eosinophils, Baseline, n= 248, 247 |
0.139
(0.1790)
|
0.146
(0.2580)
|
| Eosinophils, Week 4, n= 241, 234 |
0.040
(0.1486)
|
0.021
(0.1648)
|
| Eosinophils, Week 12, n= 228, 216 |
0.037
(0.1982)
|
-0.001
(0.1610)
|
| Eosinophils, Week 24, n= 221, 208 |
0.028
(0.1927)
|
0.005
(0.1973)
|
| Eosinophils, Week 36, n= 214, 203 |
0.048
(0.2244)
|
0.014
(0.2139)
|
| Eosinophils, Week 48, n= 206, 189 |
0.030
(0.1744)
|
0.007
(0.2274)
|
| Lymphocytes, Baseline, n= 248, 247 |
1.538
(0.6092)
|
1.573
(0.7895)
|
| Lymphocytes, Week 4, n= 241, 234 |
0.208
(0.4914)
|
0.119
(0.5493)
|
| Lymphocytes, Week 12, n= 228, 216 |
0.257
(0.5500)
|
0.156
(0.6690)
|
| Lymphocytes, Week 24, n= 221, 208 |
0.317
(0.4889)
|
0.192
(0.5910)
|
| Lymphocytes, Week 36, n= 214, 203 |
0.362
(0.5199)
|
0.178
(0.6441)
|
| Lymphocytes, Week 48, n= 206, 189 |
0.359
(0.5235)
|
0.261
(0.7098)
|
| Monocytes, Baseline, n= 248, 247 |
0.315
(0.1491)
|
0.326
(0.1606)
|
| Monocytes, Week 4, n= 241, 234 |
-0.001
(0.1558)
|
-0.015
(0.1391)
|
| Monocytes, Week 12, n= 228, 216 |
-0.010
(0.1412)
|
-0.031
(0.1369)
|
| Monocytes, Week 24, n= 221, 208 |
0.008
(0.1498)
|
-0.015
(0.1581)
|
| Monocytes, Week 36, n= 214, 203 |
-0.006
(0.1448)
|
-0.028
(0.1500)
|
| Monocytes, Week 48, n= 206, 189 |
0.001
(0.1379)
|
-0.024
(0.1638)
|
| Title | Change From Baseline in Erythrocytes at Indicated Time Points. |
|---|---|
| Description | Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n= 248, 247 |
4.27
(0.467)
|
4.28
(0.440)
|
| Week 4, n= 243, 234 |
-0.04
(0.244)
|
-0.07
(0.239)
|
| Week 12, n= 233, 220 |
-0.07
(0.351)
|
-0.09
(0.308)
|
| Week 24, n= 225, 211 |
-0.08
(0.373)
|
-0.09
(0.329)
|
| Week 36, n= 218, 203 |
-0.10
(0.384)
|
-0.08
(0.358)
|
| Week 48, n= 207, 190 |
-0.10
(0.365)
|
-0.05
(0.318)
|
| Title | Change From Baseline in Hematocrit Count at Indicated Time Points. |
|---|---|
| Description | Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n= 248, 247 |
0.3757
(0.03978)
|
0.3766
(0.03675)
|
| Week 4, n= 243, 234 |
0.0003
(0.02176)
|
-0.0042
(0.02238)
|
| Week 12, n= 233, 220 |
0.0081
(0.03157)
|
0.0000
(0.02646)
|
| Week 24, n= 225, 211 |
0.0157
(0.03209)
|
0.0051
(0.03083)
|
| Week 36, n= 218, 203 |
0.0167
(0.03451)
|
0.0062
(0.03379)
|
| Week 48, n= 207, 190 |
0.0212
(0.03293)
|
0.0107
(0.03200)
|
| Title | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points. |
|---|---|
| Description | Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Time Frame | Baseline, Week 4, 12, 24, 36, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n= 248, 247 |
88.4
(6.45)
|
88.4
(7.01)
|
| Week 4, n= 243, 234 |
0.9
(1.81)
|
0.5
(1.83)
|
| Week 12, n= 233, 220 |
3.4
(2.98)
|
1.9
(2.94)
|
| Week 24, n= 225, 211 |
5.5
(4.03)
|
3.1
(4.33)
|
| Week 36, n= 218, 203 |
6.0
(4.04)
|
3.1
(5.22)
|
| Week 48, n= 207, 190 |
7.1
(4.31)
|
3.7
(5.15)
|
| Title | Change From Baseline in Triglycerides at Week 48 |
|---|---|
| Description | Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. |
| Time Frame | Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis. |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 226 | 214 |
| Least Squares Mean (Standard Error) [Millimoles per liter] |
0.045
(0.0477)
|
0.070
(0.0477)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7053 |
| Comments | ||
| Method | Multiple Imputed Dataset - MAR | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.026 | |
| Confidence Interval |
(2-Sided) 95% -0.159 to 0.107 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in TC/HDL Ratio at Week 48 |
|---|---|
| Description | Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. |
| Time Frame | Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis. |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 226 | 214 |
| Least Squares Mean (Standard Error) [Ratio] |
-0.264
(0.0707)
|
-0.158
(0.0784)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3165 |
| Comments | ||
| Method | Multiple Imputed Dataset - MAR | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.106 | |
| Confidence Interval |
(2-Sided) 95% -0.313 to 0.101 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points |
|---|---|
| Description | Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed. |
| Time Frame | Baseline, Week 24, Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n= 221, 231 |
5.69
(27.277)
|
3.44
(8.520)
|
| Week 24, n= 179, 186 |
-1.15
(16.557)
|
-1.03
(9.091)
|
| Week 48, n= 170, 164 |
-0.68
(20.597)
|
-0.10
(9.393)
|
| Title | Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table. |
|---|---|
| Description | Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randimization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. |
| Time Frame | Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Grade 1 |
79
31.9%
|
60
24.3%
|
| Grade 2 |
94
37.9%
|
91
36.8%
|
| Grade 3 |
18
7.3%
|
37
15%
|
| Grade 4 |
3
1.2%
|
9
3.6%
|
| Title | Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs) |
|---|---|
| Description | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (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, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. |
| Time Frame | From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Any AEs |
132
53.2%
|
160
64.8%
|
| Any SAEs |
16
6.5%
|
20
8.1%
|
| Title | Summary of Maximum Post-Baseline Emergent Chemistry Toxicities |
|---|---|
| Description | Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. |
| Time Frame | Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Hyperglycaemia, Grade 1 |
23
9.3%
|
15
6.1%
|
| Hyperglycaemia, Grade 2 |
21
8.5%
|
15
6.1%
|
| Hyperglycaemia, Grade 3 |
4
1.6%
|
3
1.2%
|
| Hyperglycaemia, Grade 4 |
1
0.4%
|
0
0%
|
| Hyperkalemia, Grade 1 |
1
0.4%
|
0
0%
|
| Hyperkalemia, Grade 2 |
0
0%
|
1
0.4%
|
| Hyperkalemia, Grade 3 |
0
0%
|
0
0%
|
| Hyperkalemia, Grade 4 |
0
0%
|
0
0%
|
| Hypernatremia, Grade 1 |
1
0.4%
|
0
0%
|
| Hypernatremia, Grade 2 |
0
0%
|
0
0%
|
| Hypernatremia, Grade 3 |
0
0%
|
0
0%
|
| Hypernatremia, Grade 4 |
0
0%
|
0
0%
|
| Hypoglycaemia, Grade 1 |
9
3.6%
|
7
2.8%
|
| Hypoglycaemia, Grade 2 |
4
1.6%
|
1
0.4%
|
| Hypoglycaemia, Grade 3 |
1
0.4%
|
0
0%
|
| Hypoglycaemia, Grade 4 |
0
0%
|
0
0%
|
| Hypokalemia, Grade 1 |
18
7.3%
|
21
8.5%
|
| Hypokalemia, Grade 2 |
1
0.4%
|
0
0%
|
| Hypokalemia, Grade 3 |
0
0%
|
0
0%
|
| Hypokalemia, Grade 4 |
0
0%
|
0
0%
|
| Hyponatremia, Grade 1 |
79
31.9%
|
82
33.2%
|
| Hyponatremia, Grade 2 |
1
0.4%
|
0
0%
|
| Hyponatremia, Grade 3 |
0
0%
|
0
0%
|
| Hyponatremia, Grade 4 |
0
0%
|
0
0%
|
| Alanine aminotransferase, Grade 1 |
7
2.8%
|
11
4.5%
|
| Alanine aminotransferase, Grade 2 |
8
3.2%
|
5
2%
|
| Alanine aminotransferase, Grade 3 |
1
0.4%
|
2
0.8%
|
| Alanine aminotransferase, Grade 4 |
1
0.4%
|
0
0%
|
| Albumin, Grade 1 |
6
2.4%
|
2
0.8%
|
| Albumin, Grade 2 |
1
0.4%
|
4
1.6%
|
| Albumin, Grade 3 |
0
0%
|
0
0%
|
| Albumin, Grade 4 |
0
0%
|
0
0%
|
| Alkaline phosphatase, Grade 1 |
4
1.6%
|
17
6.9%
|
| Alkaline phosphatase, Grade 2 |
2
0.8%
|
1
0.4%
|
| Alkaline phosphatase, Grade 3 |
0
0%
|
0
0%
|
| Alkaline phosphatase, Grade 4 |
0
0%
|
0
0%
|
| Aspartate aminotransferase, Grade 1 |
17
6.9%
|
14
5.7%
|
| Aspartate aminotransferase, Grade 2 |
8
3.2%
|
5
2%
|
| Aspartate aminotransferase, Grade 3 |
1
0.4%
|
2
0.8%
|
| Aspartate aminotransferase, Grade 4 |
1
0.4%
|
0
0%
|
| Bilirubin, Grade 1 |
2
0.8%
|
52
21.1%
|
| Bilirubin, Grade 2 |
0
0%
|
86
34.8%
|
| Bilirubin, Grade 3 |
0
0%
|
57
23.1%
|
| Bilirubin, Grade 4 |
0
0%
|
5
2%
|
| Carbon dioxide, Grade 1 |
94
37.9%
|
74
30%
|
| Carbon dioxide, Grade 2 |
5
2%
|
4
1.6%
|
| Carbon dioxide, Grade 3 |
0
0%
|
0
0%
|
| Carbon dioxide, Grade 4 |
0
0%
|
0
0%
|
| Cholesterol, Grade 1 |
74
29.8%
|
47
19%
|
| Cholesterol, Grade 2 |
32
12.9%
|
13
5.3%
|
| Cholesterol, Grade 3 |
4
1.6%
|
2
0.8%
|
| Cholesterol, Grade 4 |
0
0%
|
0
0%
|
| Creatine kinase, Grade 1 |
4
1.6%
|
7
2.8%
|
| Creatine kinase, Grade 2 |
1
0.4%
|
1
0.4%
|
| Creatine kinase, Grade 3 |
4
1.6%
|
0
0%
|
| Creatine kinase, Grade 4 |
0
0%
|
1
0.4%
|
| Creatinine, Grade 1 |
5
2%
|
8
3.2%
|
| Creatinine, Grade 2 |
0
0%
|
3
1.2%
|
| Creatinine, Grade 3 |
1
0.4%
|
0
0%
|
| Creatinine, Grade 4 |
0
0%
|
0
0%
|
| LDL cholesterol calculation, Grade 1 |
53
21.4%
|
31
12.6%
|
| LDL cholesterol calculation, Grade 2 |
15
6%
|
11
4.5%
|
| LDL cholesterol calculation, Grade 3 |
7
2.8%
|
3
1.2%
|
| LDL cholesterol calculation, Grade 4 |
0
0%
|
0
0%
|
| LDL cholesterol direct, Grade 1 |
3
1.2%
|
1
0.4%
|
| LDL cholesterol direct, Grade 2 |
1
0.4%
|
0
0%
|
| LDL cholesterol direct, Grade 3 |
0
0%
|
0
0%
|
| LDL cholesterol direct, Grade 4 |
0
0%
|
0
0%
|
| Lipase, Grade 1 |
16
6.5%
|
11
4.5%
|
| Lipase, Grade 2 |
11
4.4%
|
5
2%
|
| Lipase, Grade 3 |
3
1.2%
|
2
0.8%
|
| Lipase, Grade 4 |
0
0%
|
1
0.4%
|
| Phosphate, Grade 1 |
5
2%
|
12
4.9%
|
| Phosphate, Grade 2 |
9
3.6%
|
13
5.3%
|
| Phosphate, Grade 3 |
1
0.4%
|
2
0.8%
|
| Phosphate, Grade 4 |
0
0%
|
0
0%
|
| Potassium, Grade 1 |
19
7.7%
|
21
8.5%
|
| Potassium, Grade 2 |
1
0.4%
|
1
0.4%
|
| Potassium, Grade 3 |
0
0%
|
0
0%
|
| Potassium, Grade 4 |
0
0%
|
0
0%
|
| Sodium, Grade 1 |
80
32.3%
|
82
33.2%
|
| Sodium, Grade 2 |
1
0.4%
|
0
0%
|
| Sodium, Grade 3 |
0
0%
|
0
0%
|
| Sodium, Grade 4 |
0
0%
|
0
0%
|
| Triglycerides, Grade 1 |
0
0%
|
0
0%
|
| Triglycerides, Grade 2 |
5
2%
|
2
0.8%
|
| Triglycerides, Grade 3 |
2
0.8%
|
0
0%
|
| Triglycerides, Grade 4 |
0
0%
|
0
0%
|
| Glucose, Grade 1 |
28
11.3%
|
21
8.5%
|
| Glucose, Grade 2 |
24
9.7%
|
14
5.7%
|
| Glucose, Grade 3 |
4
1.6%
|
3
1.2%
|
| Glucose, Grade 4 |
1
0.4%
|
0
0%
|
| Title | Summary of Maximum Post-Baseline Emergent Hematology Toxicities |
|---|---|
| Description | Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. |
| Time Frame | Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Hemoglobin, Grade 1 |
21
8.5%
|
30
12.1%
|
| Hemoglobin, Grade 2 |
4
1.6%
|
3
1.2%
|
| Hemoglobin, Grade 3 |
1
0.4%
|
1
0.4%
|
| Hemoglobin, Grade 4 |
0
0%
|
0
0%
|
| Leukocytes, Grade 1 |
6
2.4%
|
6
2.4%
|
| Leukocytes, Grade 2 |
1
0.4%
|
2
0.8%
|
| Leukocytes, Grade 3 |
0
0%
|
0
0%
|
| Leukocytes, Grade 4 |
0
0%
|
0
0%
|
| Neutrophils, Grade 1 |
19
7.7%
|
14
5.7%
|
| Neutrophils, Grade 2 |
7
2.8%
|
9
3.6%
|
| Neutrophils, Grade 3 |
0
0%
|
3
1.2%
|
| Neutrophils, Grade 4 |
1
0.4%
|
1
0.4%
|
| Platelets, Grade 1 |
9
3.6%
|
1
0.4%
|
| Platelets, Grade 2 |
0
0%
|
4
1.6%
|
| Platelets, Grade 3 |
1
0.4%
|
0
0%
|
| Platelets, Grade 4 |
0
0%
|
0
0%
|
| Title | Number of Participants Who Withdrew From Treatment Due to AEs |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as 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, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. |
| Time Frame | average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Number [Participants] |
11
4.4%
|
17
6.9%
|
| Title | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints |
|---|---|
| Description | Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. |
| Time Frame | Baseline, Week 24, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| BSAP, Baseline, n=244, 243 |
11.52
(3.837)
|
11.67
(5.287)
|
| BSAP, Week 24, n=219, 207 |
1.33
(3.934)
|
6.00
(5.962)
|
| BSAP, Week 48, n=202, 184 |
2.64
(5.746)
|
7.60
(7.144)
|
| Osteocalcin, Baseline, n=235, 235 |
16.60
(8.551)
|
18.27
(19.891)
|
| Osteocalcin, Week 24, n=209, 197 |
3.73
(7.484)
|
14.38
(22.205)
|
| Osteocalcin, Week 48, n=194, 178 |
5.15
(9.018)
|
16.30
(25.043)
|
| PTP, Baseline, n=246, 240 |
49.4
(24.48)
|
49.5
(23.01)
|
| PTP, Week 24, n=223, 206 |
10.1
(20.11)
|
32.0
(27.89)
|
| PTP, Week 48, n=205, 186 |
11.2
(23.05)
|
34.1
(27.28)
|
| Title | Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints |
|---|---|
| Description | Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. |
| Time Frame | Baseline, Week 24, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Baseline, n=245, 243 |
312.9
(183.68)
|
329.7
(190.02)
|
| Week 24, n=221, 207 |
89.8
(173.09)
|
272.4
(205.22)
|
| Week 48, n=202, 185 |
75.9
(173.73)
|
267.9
(200.82)
|
| Title | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 |
|---|---|
| Description | Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. |
| Time Frame | Baseline, Weeks 24, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Vitamin D, Baseline, n=247, 244 |
58.6
(30.15)
|
56.9
(22.43)
|
| Vitamin D, Week 24, n=223, 208 |
1.8
(24.95)
|
16.3
(31.66)
|
| Vitamin D, Week 48, n=206, 186 |
-1.9
(20.63)
|
8.9
(23.78)
|
| Vitamin D2, Baseline, n=247, 244 |
9.3
(3.16)
|
9.5
(3.79)
|
| Vitamin D2, Week 24, n=223, 208 |
0.3
(6.04)
|
1.0
(7.88)
|
| Vitamin D2, Week 48, n=206, 186 |
0.1
(4.71)
|
0.9
(11.00)
|
| Vitamin D3, Baseline, n=247, 244 |
58.1
(30.07)
|
56.1
(22.59)
|
| Vitamin D3, Week 24, n=223, 208 |
1.5
(24.33)
|
15.2
(31.39)
|
| Vitamin D3, Week 48, n=206, 186 |
-1.9
(20.56)
|
7.9
(21.72)
|
| Title | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline |
|---|---|
| Description | Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC. |
| Time Frame | Baseline, Weeks 24, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| BSAP, n=202, 183 |
1.188
|
1.629
|
| PTP, n=202, 184 |
1.214
|
1.752
|
| Osteocalcin, n=194, 178 |
1.282
|
2.039
|
| Type 1 Collagen C-Telopeptide, n=202, 184 |
1.257
|
1.918
|
| Vitamin D, n=206, 186 |
0.987
|
1.158
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of ratio |
| Estimated Value | 0.729 | |
| Confidence Interval |
(2-Sided) 95% 0.683 to 0.779 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | BSAP ratio of Week 48 result over Baseline | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of ratio |
| Estimated Value | 0.693 | |
| Confidence Interval |
(2-Sided) 95% 0.647 to 0.741 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | PTP ratio of Week 48 result over Baseline | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of ratio |
| Estimated Value | 0.629 | |
| Confidence Interval |
(2-Sided) 95% 0.581 to 0.680 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Osteocalcin ratio of Week 48 result over Baseline | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of ratio |
| Estimated Value | 0.655 | |
| Confidence Interval |
(2-Sided) 95% 0.609 to 0.706 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of ratio |
| Estimated Value | 0.852 | |
| Confidence Interval |
(2-Sided) 95% 0.794 to 0.914 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Vitamin D ratio of Week 48 result over Baseline | |
| Title | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS |
|---|---|
| Description | The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. |
| Time Frame | Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Total Score, Baseline, n=245, 240 |
38.6
(4.33)
|
38.5
(4.47)
|
| Total Score, Week 48, n=205, 192 |
0.0
(5.15)
|
0.1
(5.66)
|
| MCS, Baseline, n=245, 240 |
48.310
(10.3025)
|
47.670
(10.4284)
|
| MCS, Week 48, n=205, 192 |
2.397
(10.5232)
|
2.329
(9.9782)
|
| PCS, Baseline, n=245, 240 |
50.663
(8.4227)
|
50.374
(8.0038)
|
| PCS, Week 48, n=205, 192 |
1.905
(8.6309)
|
1.444
(8.3938)
|
| Title | Assessment of HIVTSQs Total Score at Indicated Timepoints. |
|---|---|
| Description | The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. |
| Time Frame | Week 4, 12, 24, 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Week 4, n=243, 239 |
54.0
(6.37)
|
51.9
(8.53)
|
| Week 12, n=236, 226 |
56.1
(5.38)
|
53.6
(7.67)
|
| Week 24, n=225, 211 |
56.8
(4.55)
|
54.3
(7.27)
|
| Week 48, n=206, 191 |
57.0
(4.38)
|
55.4
(6.00)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | Week 4 | |
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Week 12 | |
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Week 24 | |
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | Week 48 | |
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups |
|---|---|
| Description | Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 248 | 247 |
| Age, <50 Years, n=212, 212 |
80
32.3%
|
71
28.7%
|
| Age, >=50 Years, n=36, 35 |
92
37.1%
|
74
30%
|
| Race, White, n=115, 107 |
86
34.7%
|
80
32.4%
|
| Race, Non-White, n=133,140 |
78
31.5%
|
64
25.9%
|
| Race, African-American/African Heritage, n=102,108 |
74
29.8%
|
67
27.1%
|
| Non-African-American/African Heritage, n=146, 139 |
88
35.5%
|
75
30.4%
|
| BPHR, <1000, n=5, 10 |
60
24.2%
|
80
32.4%
|
| BPHR, 1000 to <10,000, n=66, 62 |
83
33.5%
|
77
31.2%
|
| BPHR, 10,000 to <50,000, n=83, 81 |
84
33.9%
|
74
30%
|
| BPHR, 50,000 to <=100,000, n=25, 28 |
80
32.3%
|
64
25.9%
|
| BPHR, >100,000, n=69, 66 |
80
32.3%
|
64
25.9%
|
| BCCC, <200, n=64, 49 |
81
32.7%
|
69
27.9%
|
| BCCC, >=200, n=184, 198 |
82
33.1%
|
72
29.1%
|
| BCCC, <50, n=9, 15 |
67
27%
|
60
24.3%
|
| BCCC, 50 to <200, n=55, 34 |
84
33.9%
|
74
30%
|
| BCCC, 200 to <350, n=66, 74 |
89
35.9%
|
73
29.6%
|
| BCCC, 350 to <500, n=56, 65 |
79
31.9%
|
74
30%
|
| BCCC, >=500, n=62, 59 |
77
31%
|
68
27.5%
|
| CDC category, A, n=210, 208 |
81
32.7%
|
71
28.7%
|
| CDC category, B, n=27, 30 |
81
32.7%
|
77
31.2%
|
| CDC category, C, n=11, 9 |
91
36.7%
|
56
22.7%
|
| HIV-1 subtype: B vs Non-B, B, n=95, 111 |
80
32.3%
|
69
27.9%
|
| IV-1 subtype: B vs Non-B, non-B, n=140, 131 |
84
33.9%
|
73
29.6%
|
| Title | Number of Participants With Post-Baseline HIV-1 Disease Progression |
|---|---|
| Description | Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. |
| Time Frame | Up to week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed. |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 7 | 7 |
| CDC Class A to CDC Class C |
5
2%
|
4
1.6%
|
| CDC Class B to CDC Class C |
1
0.4%
|
2
0.8%
|
| CDC Class C to new CDC Class C |
0
0%
|
0
0%
|
| CDC Class A, B or C to Death |
1
0.4%
|
1
0.4%
|
| Title | Number of Participants With Treatment Emergent Resistances |
|---|---|
| Description | Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. |
| Time Frame | Up to week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| On-treatment Genotypic Resistance Population |
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD |
|---|---|---|
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. |
| Measure Participants | 6 | 4 |
| Any mutation |
0
0%
|
1
0.4%
|
| INSTI |
0
0%
|
0
0%
|
| NRTI |
0
0%
|
1
0.4%
|
| M184M/I/V |
0
0%
|
1
0.4%
|
| PI |
0
0%
|
1
0.4%
|
Adverse Events
| Time Frame | AEs and SAEs were collected from start of study treatment until end of study treatment (average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment. AEs were identified post-hoc for two ATV+RTV+TDF/FTC FDC subjects at one site. These AEs are not included and are not considered to affect the overall safety findings. | |||
| Arm/Group Title | DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD | ||
| Arm/Group Description | Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TD FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TD FDC was discontinued/terminated. | Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. | ||
All Cause Mortality |
||||
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/248 (6.5%) | 20/247 (8.1%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 1/248 (0.4%) | 0/247 (0%) | ||
| Acute myocardial infarction | 1/248 (0.4%) | 0/247 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/248 (0.4%) | 1/247 (0.4%) | ||
| Nausea | 0/248 (0%) | 1/247 (0.4%) | ||
| Vomiting | 0/248 (0%) | 1/247 (0.4%) | ||
| General disorders | ||||
| Death | 1/248 (0.4%) | 0/247 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis chronic | 0/248 (0%) | 1/247 (0.4%) | ||
| Hepatitis acute | 0/248 (0%) | 1/247 (0.4%) | ||
| Infections and infestations | ||||
| Pneumonia | 1/248 (0.4%) | 2/247 (0.8%) | ||
| Arthritis infective | 0/248 (0%) | 1/247 (0.4%) | ||
| Bacteraemia | 1/248 (0.4%) | 0/247 (0%) | ||
| Cellulitis | 0/248 (0%) | 1/247 (0.4%) | ||
| Herpes simplex | 0/248 (0%) | 1/247 (0.4%) | ||
| Infected skin ulcer | 1/248 (0.4%) | 0/247 (0%) | ||
| Lower respiratory tract infection | 1/248 (0.4%) | 0/247 (0%) | ||
| Malaria | 1/248 (0.4%) | 0/247 (0%) | ||
| Mastoiditis | 1/248 (0.4%) | 0/247 (0%) | ||
| Meningitis viral | 0/248 (0%) | 1/247 (0.4%) | ||
| Otitis media chronic | 1/248 (0.4%) | 0/247 (0%) | ||
| Pneumocystis jirovecii pneumonia | 1/248 (0.4%) | 0/247 (0%) | ||
| Salpingitis | 1/248 (0.4%) | 0/247 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/248 (0.4%) | 0/247 (0%) | ||
| Thermal burn | 1/248 (0.4%) | 0/247 (0%) | ||
| Toxicity to various agents | 1/248 (0.4%) | 0/247 (0%) | ||
| Investigations | ||||
| Blood creatinine increased | 0/248 (0%) | 1/247 (0.4%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetic ketoacidosis | 0/248 (0%) | 1/247 (0.4%) | ||
| Electrolyte imbalance | 1/248 (0.4%) | 0/247 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteonecrosis | 0/248 (0%) | 1/247 (0.4%) | ||
| Scleroderma | 0/248 (0%) | 1/247 (0.4%) | ||
| Nervous system disorders | ||||
| Amnesia | 1/248 (0.4%) | 0/247 (0%) | ||
| Cerebrovascular accident | 1/248 (0.4%) | 0/247 (0%) | ||
| Seizure | 0/248 (0%) | 1/247 (0.4%) | ||
| Transient ischaemic attack | 0/248 (0%) | 1/247 (0.4%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion spontaneous | 0/248 (0%) | 1/247 (0.4%) | ||
| Psychiatric disorders | ||||
| Acute psychosis | 0/248 (0%) | 1/247 (0.4%) | ||
| Intentional self-injury | 0/248 (0%) | 1/247 (0.4%) | ||
| Panic attack | 1/248 (0.4%) | 0/247 (0%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 1/248 (0.4%) | 0/247 (0%) | ||
| Chronic kidney disease | 1/248 (0.4%) | 0/247 (0%) | ||
| Reproductive system and breast disorders | ||||
| Endometriosis | 0/248 (0%) | 1/247 (0.4%) | ||
| Rectocele | 0/248 (0%) | 1/247 (0.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 0/248 (0%) | 1/247 (0.4%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 1/248 (0.4%) | 0/247 (0%) | ||
| Diabetic foot | 1/248 (0.4%) | 0/247 (0%) | ||
| Skin ulcer | 0/248 (0%) | 1/247 (0.4%) | ||
| Vascular disorders | ||||
| Hypertensive emergency | 1/248 (0.4%) | 0/247 (0%) | ||
| Peripheral artery stenosis | 0/248 (0%) | 1/247 (0.4%) | ||
Other (Not Including Serious) Adverse Events |
||||
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 132/248 (53.2%) | 160/247 (64.8%) | ||
| Eye disorders | ||||
| Ocular icterus | 0/248 (0%) | 18/247 (7.3%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 47/248 (19%) | 48/247 (19.4%) | ||
| Diarrhoea | 24/248 (9.7%) | 32/247 (13%) | ||
| Dyspepsia | 9/248 (3.6%) | 25/247 (10.1%) | ||
| Vomiting | 17/248 (6.9%) | 17/247 (6.9%) | ||
| Abdominal pain | 8/248 (3.2%) | 17/247 (6.9%) | ||
| General disorders | ||||
| Fatigue | 8/248 (3.2%) | 14/247 (5.7%) | ||
| Hepatobiliary disorders | ||||
| Jaundice | 0/248 (0%) | 14/247 (5.7%) | ||
| Hyperbilirubinaemia | 0/248 (0%) | 13/247 (5.3%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 19/248 (7.7%) | 20/247 (8.1%) | ||
| Nasopharyngitis | 16/248 (6.5%) | 14/247 (5.7%) | ||
| Urinary tract infection | 13/248 (5.2%) | 16/247 (6.5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 13/248 (5.2%) | 17/247 (6.9%) | ||
| Nervous system disorders | ||||
| Headache | 29/248 (11.7%) | 32/247 (13%) | ||
| Dizziness | 13/248 (5.2%) | 15/247 (6.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 10/248 (4%) | 26/247 (10.5%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 12/248 (4.8%) | 20/247 (8.1%) | ||
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 | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01910402
Other Study ID Numbers:
- 117172
- 2012-005823-34
First Posted:
Jul 29, 2013
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022