A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
Sponsor
Janssen Scientific Affairs, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03227861
Collaborator
(none)
109
16
1
25.1
6.8
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
109 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Receiving Care in a Test and Treat Model of Care
Actual Study Start Date
:
Jul 31, 2017
Actual Primary Completion Date
:
Jan 3, 2019
Actual Study Completion Date
:
Sep 4, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit. |
Drug: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach [Week 48]
Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is < 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
Secondary Outcome Measures
- Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 [Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48]
Change from baseline in log10 HIV-1 RNA viral load (<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 [Week 24]
Percentage of participants with HIV-1 RNA < 50 copies/mL were reported.
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48 [Baseline, Weeks 12, 24 and 48]
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.
- Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules [Up to Week 48]
Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula < 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (>=) 2.5*upper limit of normal (ULN); c). Serum lipase >=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.
- Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) [Up to Week 48]
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
- Percentage of Participants Experiencing Grade 3 and 4 Adverse Events [Up to Week 48]
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
- Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities [Up to Week 48]
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
- Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings [Up to Day 35]
Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.
- Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) [Baseline (Day 1)]
Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [<500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility).
- Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48 [Week 24 and 48]
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
- Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF) [Up to Week 48]
Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
- Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment [Up to Week 48]
Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.
- Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit [Up to Week 48]
Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.
- Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 [Weeks 4, 8, 12, 24, 36, and 48]
Percentage of participants with treatment adherence >95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count.
- Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 [Weeks 4, 8, 12, 24, 36, and 48]
Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.
- Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48 [Weeks 4, 24, and 48]
The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. 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). The higher the score, the greater the treatment satisfaction.
- Number of Participants With Hospitalizations [Up to Week 48]
Number of participants with hospitalizations (overnight) was reported.
- Duration of Hospitalizations [Up to Week 48]
Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.
- Number of Participants With Outpatient Visits [Up to Week 48]
Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.
- Number of Participants With Emergency Room Visits [Up to Week 48]
Number of participants with emergency room visits was reported.
- Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) [Up to Week 48]
Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.
- Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96 [Up to Week 96]
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
- Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96 [Up to Week 96]
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
- Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96 [Up to Week 96]
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
- Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96 [Weeks 72 and 96]
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1 ribonucleic acid (RNA) viral load greater than or equal to (>=) 5,000 copies per milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1 RNA viral load (>=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once within 1 week of initial HIV-1 RNA viral load test
-
Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure prophylaxis (PrEP)
-
Must be able to swallow whole tablets
-
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study drug
-
A woman of childbearing potential must have a negative urine pregnancy test at screening
Exclusion Criteria:
-
Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining condition that in the judgement of the investigator would increase the risk of morbidity or mortality
-
Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF FDC)
-
Known history of cirrhosis as diagnosed based on local practices
-
Known history of chronic ([>=] 3 months) renal insufficiency, defined as having an estimated glomerular filtration rate (eGFR) less than (<) 50 milliliter per minute (mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula
-
Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spectrum Medical Group | Phoenix | Arizona | United States | 85012 |
| 2 | The Office of Franco Felizarta, MD | Bakersfield | California | United States | 93301 |
| 3 | Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center | Los Angeles | California | United States | 90028 |
| 4 | Whitman Walker Health | Washington | District of Columbia | United States | 20009 |
| 5 | Midway Immunology and Research Center | Fort Pierce | Florida | United States | 34982 |
| 6 | University of Miami | Miami | Florida | United States | 33136 |
| 7 | Orlando Immunology Center | Orlando | Florida | United States | 32803 |
| 8 | Chatham County Health Department | Savannah | Georgia | United States | 31401 |
| 9 | The Ruth M. Rothstein CORE Center | Chicago | Illinois | United States | 60612 |
| 10 | Saint Michael's Medical Center - Infectious Disease | Newark | New Jersey | United States | 07102 |
| 11 | Southwest CARE Center | Albuquerque | New Mexico | United States | 87109 |
| 12 | Southwest CARE Center | Santa Fe | New Mexico | United States | 87505 |
| 13 | North Texas Infectious Diseases Consultants | Dallas | Texas | United States | 75246 |
| 14 | Texas Centers for Infectious Disease Associates | Fort Worth | Texas | United States | 76104 |
| 15 | Therapeutic Concepts - Donald R Watkins Foundation | Houston | Texas | United States | 77004 |
| 16 | Gordon Crofoot, MD | Houston | Texas | United States | 77098 |
Sponsors and Collaborators
- Janssen Scientific Affairs, LLC
Investigators
- Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT03227861
Other Study ID Numbers:
- CR108345
- TMC114FD2HTX3002
First Posted:
Jul 24, 2017
Last Update Posted:
Sep 25, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Out of 97 participants who completed the main study, 80 participants continued into the extension phase and were treated with Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | D/C/F/TAF |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). |
| Period Title: Main Study Period (Week 0 to Week 48) | |
| STARTED | 109 |
| COMPLETED | 97 |
| NOT COMPLETED | 12 |
| Period Title: Main Study Period (Week 0 to Week 48) | |
| STARTED | 80 |
| COMPLETED | 0 |
| NOT COMPLETED | 80 |
Baseline Characteristics
| Arm/Group Title | D/C/F/TAF |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Overall Participants | 109 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
32.5
(12.02)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
14
12.8%
|
| Male |
95
87.2%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
0.9%
|
| Asian |
3
2.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
35
32.1%
|
| White |
65
59.6%
|
| More than one race |
3
2.8%
|
| Unknown or Not Reported |
2
1.8%
|
| Region of Enrollment (Count of Participants) | |
| United States |
109
100%
|
Outcome Measures
| Title | Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach |
|---|---|
| Description | Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is < 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Number (95% Confidence Interval) [Percentage of participants] |
84.4
77.4%
|
| Title | Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 |
|---|---|
| Description | Change from baseline in log10 HIV-1 RNA viral load (<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all participants who were randomized and received at least one dose of study treatment in study. Here, n (number analyzed) signifies participants analyzed for this outcome measure (OM) at specified timepoints. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Change at Week 2 |
-1.65
(0.056)
|
| Change at Week 4 |
-2.02
(0.066)
|
| Change at Week 8 |
-2.43
(0.086)
|
| Change at Week 12 |
-2.78
(0.080)
|
| Change at Week 24 |
-3.08
(0.096)
|
| Change at Week 36 |
-3.14
(0.102)
|
| Change at Week 48 |
-3.14
(0.099)
|
| Title | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 |
|---|---|
| Description | Percentage of participants with HIV-1 RNA < 50 copies/mL were reported. |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Number (95% Confidence Interval) [Percentage of Participants] |
81.7
75%
|
| Title | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48 |
|---|---|
| Description | The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed. |
| Time Frame | Baseline, Weeks 12, 24 and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Change at Week 12 |
149.56
(16.621)
|
| Change at Week 24 |
182.11
(16.885)
|
| Change at Week 48 |
222.60
(20.618)
|
| Title | Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules |
|---|---|
| Description | Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula < 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (>=) 2.5*upper limit of normal (ULN); c). Serum lipase >=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Count of Participants [Participants] |
3
2.8%
|
| Title | Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) |
|---|---|
| Description | Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Number [Percentage of participants] |
0.9
0.8%
|
| Title | Percentage of Participants Experiencing Grade 3 and 4 Adverse Events |
|---|---|
| Description | AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Grade 3 |
11.9
10.9%
|
| Grade 4 |
0.9
0.8%
|
| Title | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities |
|---|---|
| Description | Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| ALT: Grade 3 |
0
0%
|
| ALT: Grade 4 |
2.8
2.6%
|
| AST: Grade 3 |
0.9
0.8%
|
| AST: Grade 4 |
3.7
3.4%
|
| Calcium: Grade 3 |
0
0%
|
| Calcium: Grade 4 |
0.9
0.8%
|
| Glucose: Grade 3 |
0.9
0.8%
|
| Glucose: Grade 4 |
0
0%
|
| Hyperbilirubinemia: Grade 3 |
2.8
2.6%
|
| Hyperbilirubinemia: Grade 4 |
0
0%
|
| Hypophosphatemia: Grade 3 |
0.9
0.8%
|
| Hypophosphatemia: Grade 4 |
0
0%
|
| Sodium: Grade 3 |
0
0%
|
| Sodium: Grade 4 |
0.9
0.8%
|
| Absolute Lymphocytes Count: Grade 3 |
0.9
0.8%
|
| Absolute Lymphocytes Count: Grade 4 |
0.9
0.8%
|
| Platelet Count: Grade 3 |
0
0%
|
| Platelet Count: Grade 4 |
0.9
0.8%
|
| Title | Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings |
|---|---|
| Description | Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study. |
| Time Frame | Up to Day 35 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Number [Percentage of participants] |
0
0%
|
| Title | Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs) |
|---|---|
| Description | Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [<500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility). |
| Time Frame | Baseline (Day 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this endpoint. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 102 |
| Primary PI RAM |
4.9
4.5%
|
| Secondary PI RAM |
98.0
89.9%
|
| Darunavir RAM |
0
0%
|
| Emtricitabine RAM |
2.0
1.8%
|
| NNRTI RAM |
27.5
25.2%
|
| Primary INI RAM |
0
0%
|
| Secondary INI RAM |
4.9
4.5%
|
| Title | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48 |
|---|---|
| Description | Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. |
| Time Frame | Week 24 and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Week 24 |
0
0%
|
| Week 48 |
0
0%
|
| Title | Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF) |
|---|---|
| Description | Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Number [Percentage of participants] |
0
0%
|
| Title | Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment |
|---|---|
| Description | Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Number [Percentage of participants] |
3.67
3.4%
|
| Title | Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit |
|---|---|
| Description | Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified ITT analysis set included all participants who were randomized and received at least one dose of study treatment and are HIV-1 positive after enrollment. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. Here, n (number analyzed) signifies participants analyzed at specified categories. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 11 |
| Retention in care: Completed |
63.6
58.3%
|
| Documented Clinical Visit |
85.7
78.6%
|
| Title | Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48 |
|---|---|
| Description | Percentage of participants with treatment adherence >95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count. |
| Time Frame | Weeks 4, 8, 12, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| >95% at Week 4 |
83.5
76.6%
|
| >95% at Week 8 |
84.5
77.5%
|
| >95% at Week 12 |
79.4
72.8%
|
| >95% at Week 24 |
76.5
70.2%
|
| >95% at Week 36 |
75.8
69.5%
|
| >95% at Week 48 |
65.6
60.2%
|
| Title | Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 |
|---|---|
| Description | Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported. |
| Time Frame | Weeks 4, 8, 12, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Week 4 |
99.76
(2.440)
91.5%
|
| Week 8 |
99.50
(3.518)
91.3%
|
| Week 12 |
99.02
(6.967)
90.8%
|
| Week 24 |
98.04
(10.949)
89.9%
|
| Week 36 |
99.49
(3.535)
91.3%
|
| Week 48 |
99.48
(3.571)
91.3%
|
| Title | Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48 |
|---|---|
| Description | The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. 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). The higher the score, the greater the treatment satisfaction. |
| Time Frame | Weeks 4, 24, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Week 4 |
56.52
(0.472)
|
| Week 24 |
57.87
(0.387)
|
| Week 48 |
57.88
(0.442)
|
| Title | Number of Participants With Hospitalizations |
|---|---|
| Description | Number of participants with hospitalizations (overnight) was reported. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Count of Participants [Participants] |
11
10.1%
|
| Title | Duration of Hospitalizations |
|---|---|
| Description | Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 11 |
| Median (Full Range) [Days] |
5.0
|
| Title | Number of Participants With Outpatient Visits |
|---|---|
| Description | Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| General practitioner visit |
33
30.3%
|
| Specialist visit |
28
25.7%
|
| Nurse practitioner visit |
16
14.7%
|
| Physician assistant visit |
6
5.5%
|
| Home healthcare nurse visit |
0
0%
|
| Other visit |
25
22.9%
|
| Title | Number of Participants With Emergency Room Visits |
|---|---|
| Description | Number of participants with emergency room visits was reported. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Count of Participants [Participants] |
19
17.4%
|
| Title | Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU]) |
|---|---|
| Description | Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit. |
| Time Frame | Up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies those participants who were evaluable for the specified categories. |
| Arm/Group Title | D/C/F/TAF: Main Study |
|---|---|
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Measure Participants | 109 |
| Overnight hospitalization |
2035.0
|
| Hospital day care ward (without overnight) |
341.0
|
| Emergency room visit |
212.0
|
| General practitioner visit |
142.0
|
| Specialist visit |
94.0
|
| Nurse practitioner visit |
66.0
|
| Physician assistant visit |
47.0
|
| Other visit |
148.0
|
| Title | Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96 |
|---|---|
| Description | Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Time Frame | Up to Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. |
| Arm/Group Title | D/C/F/TAF: Extension Study |
|---|---|
| Arm/Group Description | Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). |
| Measure Participants | 80 |
| Number [Percentage of participants] |
1.3
1.2%
|
| Title | Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96 |
|---|---|
| Description | AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. |
| Time Frame | Up to Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. |
| Arm/Group Title | D/C/F/TAF: Extension Study |
|---|---|
| Arm/Group Description | Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). |
| Measure Participants | 80 |
| Grade 3 |
7.5
6.9%
|
| Grade 4 |
2.5
2.3%
|
| Title | Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96 |
|---|---|
| Description | Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable. |
| Time Frame | Up to Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. |
| Arm/Group Title | D/C/F/TAF: Extension Study |
|---|---|
| Arm/Group Description | Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). |
| Measure Participants | 80 |
| Glucose: Grade 3 |
2.5
2.3%
|
| Glucose: Grade 4 |
0
0%
|
| Hypophosphatemia: Grade 3 |
1.3
1.2%
|
| Hypophosphatemia: Grade 4 |
0
0%
|
| Title | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96 |
|---|---|
| Description | Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. |
| Time Frame | Weeks 72 and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. Here 'n' (number analyzed) signifies number of participants with observed virologic response at specified timepoints. |
| Arm/Group Title | D/C/F/TAF: Extension Study |
|---|---|
| Arm/Group Description | Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). |
| Measure Participants | 80 |
| Week 72 |
10.6
9.7%
|
| Week 96 |
9.1
8.3%
|
Adverse Events
| Time Frame | Main study: Up to 48 Weeks; Extension Study: Up to 96 Weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The safety analysis was performed on the Intent-to-treat analysis set (ITT) analysis set during main study (Week 0-48) included all the participants who were randomized and received at least one dose of study treatment in the study and safety analysis set (SAS) was used for the analyses during the extension study (Week 48-96) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug. | |||
| Arm/Group Title | D/C/F/TAF: Main Study | D/C/F/TAF: Extension Study | ||
| Arm/Group Description | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. | Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). | ||
All Cause Mortality |
||||
| D/C/F/TAF: Main Study | D/C/F/TAF: Extension Study | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/109 (0%) | 0/80 (0%) | ||
Serious Adverse Events |
||||
| D/C/F/TAF: Main Study | D/C/F/TAF: Extension Study | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/109 (9.2%) | 4/80 (5%) | ||
| Gastrointestinal disorders | ||||
| Colitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Pancreatitis Acute | 1/109 (0.9%) | 0/80 (0%) | ||
| Infections and infestations | ||||
| Appendicitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Cellulitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Gastroenteritis | 0/109 (0%) | 0/80 (0%) | ||
| Pneumonia | 1/109 (0.9%) | 0/80 (0%) | ||
| Meningitis aseptic | 0/109 (0%) | 1/80 (1.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Abdominal Injury | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Muscle Rupture | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Road Traffic Accident | 1/109 (0.9%) | 0/80 (0%) | ||
| Head injury | 0/109 (0%) | 1/80 (1.3%) | ||
| Nervous system disorders | ||||
| Seizure | 1/109 (0.9%) | 0/80 (0%) | ||
| Psychiatric disorders | ||||
| Mania | 1/109 (0.9%) | 0/80 (0%) | ||
| Psychotic Disorder | 1/109 (0.9%) | 0/80 (0%) | ||
| Suicidal Ideation | 1/109 (0.9%) | 0/80 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 0/109 (0%) | 1/80 (1.3%) | ||
| Pulmonary Embolism | 1/109 (0.9%) | 0/80 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| D/C/F/TAF: Main Study | D/C/F/TAF: Extension Study | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 92/109 (84.4%) | 45/80 (56.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Eosinophilia | 2/109 (1.8%) | 0/80 (0%) | ||
| Leukocytosis | 1/109 (0.9%) | 0/80 (0%) | ||
| Lymphadenopathy | 6/109 (5.5%) | 3/80 (3.8%) | ||
| Splenomegaly | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Cardiac disorders | ||||
| Bradycardia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Tachycardia | 2/109 (1.8%) | 0/80 (0%) | ||
| Ear and labyrinth disorders | ||||
| Motion Sickness | 1/109 (0.9%) | 0/80 (0%) | ||
| Endocrine disorders | ||||
| Goitre | 0/109 (0%) | 1/80 (1.3%) | ||
| Hypogonadism | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Eye disorders | ||||
| Blindness Transient | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Lacrimation Increased | 1/109 (0.9%) | 0/80 (0%) | ||
| Photophobia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Photopsia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal Discomfort | 1/109 (0.9%) | 0/80 (0%) | ||
| Abdominal Distension | 1/109 (0.9%) | 0/80 (0%) | ||
| Abdominal Pain | 3/109 (2.8%) | 3/80 (3.8%) | ||
| Abdominal Pain Lower | 2/109 (1.8%) | 0/80 (0%) | ||
| Anogenital Dysplasia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Anorectal Discomfort | 1/109 (0.9%) | 0/80 (0%) | ||
| Constipation | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Dental Caries | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Diarrhoea | 27/109 (24.8%) | 5/80 (6.3%) | ||
| Duodenogastric Reflux | 1/109 (0.9%) | 0/80 (0%) | ||
| Dyspepsia | 3/109 (2.8%) | 0/80 (0%) | ||
| Enterocolitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Food Poisoning | 1/109 (0.9%) | 0/80 (0%) | ||
| Gastritis | 0/109 (0%) | 1/80 (1.3%) | ||
| Gastrooesophageal Reflux Disease | 1/109 (0.9%) | 0/80 (0%) | ||
| Haemorrhoids | 1/109 (0.9%) | 0/80 (0%) | ||
| Lip Swelling | 1/109 (0.9%) | 0/80 (0%) | ||
| Nausea | 17/109 (15.6%) | 1/80 (1.3%) | ||
| Paraesthesia Oral | 1/109 (0.9%) | 0/80 (0%) | ||
| Toothache | 3/109 (2.8%) | 0/80 (0%) | ||
| Vomiting | 10/109 (9.2%) | 1/80 (1.3%) | ||
| Abdominal pain upper | 0/109 (0%) | 1/80 (1.3%) | ||
| General disorders | ||||
| Chest Discomfort | 1/109 (0.9%) | 0/80 (0%) | ||
| Chest Pain | 1/109 (0.9%) | 0/80 (0%) | ||
| Chills | 1/109 (0.9%) | 0/80 (0%) | ||
| Fatigue | 7/109 (6.4%) | 2/80 (2.5%) | ||
| Influenza Like Illness | 2/109 (1.8%) | 0/80 (0%) | ||
| Malaise | 1/109 (0.9%) | 0/80 (0%) | ||
| Non-Cardiac Chest Pain | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Oedema Peripheral | 1/109 (0.9%) | 0/80 (0%) | ||
| Pain | 2/109 (1.8%) | 1/80 (1.3%) | ||
| Peripheral Swelling | 0/109 (0%) | 1/80 (1.3%) | ||
| Pyrexia | 6/109 (5.5%) | 0/80 (0%) | ||
| Hepatobiliary disorders | ||||
| Gallbladder Polyp | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Hepatic Cyst | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Hepatic Steatosis | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Hepatotoxicity | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Immune system disorders | ||||
| Drug Hypersensitivity | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Seasonal Allergy | 2/109 (1.8%) | 0/80 (0%) | ||
| Infections and infestations | ||||
| Abscess | 1/109 (0.9%) | 0/80 (0%) | ||
| Abscess Limb | 1/109 (0.9%) | 0/80 (0%) | ||
| Acarodermatitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Acute Hepatitis C | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Acute Sinusitis | 3/109 (2.8%) | 1/80 (1.3%) | ||
| Anal Chlamydia Infection | 4/109 (3.7%) | 3/80 (3.8%) | ||
| Anorectal Human Papilloma Virus Infection | 1/109 (0.9%) | 0/80 (0%) | ||
| Bronchitis | 2/109 (1.8%) | 0/80 (0%) | ||
| Cellulitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Cellulitis Staphylococcal | 1/109 (0.9%) | 0/80 (0%) | ||
| Chlamydial Infection | 4/109 (3.7%) | 1/80 (1.3%) | ||
| Conjunctivitis | 3/109 (2.8%) | 1/80 (1.3%) | ||
| Conjunctivitis Viral | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Cytomegalovirus Syndrome | 1/109 (0.9%) | 0/80 (0%) | ||
| Epididymitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Folliculitis | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Gastroenteritis Viral | 3/109 (2.8%) | 0/80 (0%) | ||
| Genitourinary Chlamydia Infection | 1/109 (0.9%) | 0/80 (0%) | ||
| Gonorrhoea | 4/109 (3.7%) | 1/80 (1.3%) | ||
| Hepatitis A | 0/109 (0%) | 1/80 (1.3%) | ||
| Herpes Zoster | 1/109 (0.9%) | 0/80 (0%) | ||
| Influenza | 3/109 (2.8%) | 0/80 (0%) | ||
| Nasopharyngitis | 4/109 (3.7%) | 1/80 (1.3%) | ||
| Oral Herpes | 1/109 (0.9%) | 0/80 (0%) | ||
| Oropharyngeal Gonococcal Infection | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Otitis Externa | 1/109 (0.9%) | 0/80 (0%) | ||
| Otitis Media | 1/109 (0.9%) | 0/80 (0%) | ||
| Papilloma Viral Infection | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Periodontitis | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Pharyngeal Chlamydia Infection | 1/109 (0.9%) | 0/80 (0%) | ||
| Pharyngitis | 4/109 (3.7%) | 0/80 (0%) | ||
| Pilonidal Cyst | 1/109 (0.9%) | 0/80 (0%) | ||
| Proctitis Gonococcal | 4/109 (3.7%) | 1/80 (1.3%) | ||
| Pyuria | 1/109 (0.9%) | 0/80 (0%) | ||
| Secondary Syphilis | 1/109 (0.9%) | 0/80 (0%) | ||
| Sinusitis | 2/109 (1.8%) | 1/80 (1.3%) | ||
| Skin Infection | 1/109 (0.9%) | 0/80 (0%) | ||
| Syphilis | 4/109 (3.7%) | 3/80 (3.8%) | ||
| Tonsillitis | 2/109 (1.8%) | 1/80 (1.3%) | ||
| Tooth Infection | 1/109 (0.9%) | 0/80 (0%) | ||
| Tuberculosis | 1/109 (0.9%) | 0/80 (0%) | ||
| Upper Respiratory Tract Infection | 5/109 (4.6%) | 3/80 (3.8%) | ||
| Urinary Tract Infection | 1/109 (0.9%) | 0/80 (0%) | ||
| Viral Pharyngitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Viral Upper Respiratory Tract Infection | 1/109 (0.9%) | 0/80 (0%) | ||
| Vulvovaginal Candidiasis | 1/109 (0.9%) | 0/80 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Anal Injury | 1/109 (0.9%) | 0/80 (0%) | ||
| Exposure to Communicable Disease | 1/109 (0.9%) | 0/80 (0%) | ||
| Human Bite | 1/109 (0.9%) | 0/80 (0%) | ||
| Ligament Sprain | 2/109 (1.8%) | 0/80 (0%) | ||
| Muscle Strain | 1/109 (0.9%) | 0/80 (0%) | ||
| Post-Traumatic Neck Syndrome | 1/109 (0.9%) | 0/80 (0%) | ||
| Procedural Pain | 2/109 (1.8%) | 0/80 (0%) | ||
| Skin Laceration | 1/109 (0.9%) | 0/80 (0%) | ||
| Corneal abrasion | 0/109 (0%) | 1/80 (1.3%) | ||
| Hand fracture | 0/109 (0%) | 1/80 (1.3%) | ||
| Rib fracture | 0/109 (0%) | 1/80 (1.3%) | ||
| Investigations | ||||
| Blood Pressure Diastolic Increased | 1/109 (0.9%) | 0/80 (0%) | ||
| Blood Pressure Increased | 3/109 (2.8%) | 1/80 (1.3%) | ||
| Body Temperature Increased | 1/109 (0.9%) | 0/80 (0%) | ||
| Cardiac Murmur | 1/109 (0.9%) | 0/80 (0%) | ||
| Weight Decreased | 10/109 (9.2%) | 3/80 (3.8%) | ||
| Weight Increased | 1/109 (0.9%) | 2/80 (2.5%) | ||
| Metabolism and nutrition disorders | ||||
| Abnormal Loss of Weight | 3/109 (2.8%) | 1/80 (1.3%) | ||
| Dyslipidaemia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Gout | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Hyperglycaemia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Hyperlipidaemia | 2/109 (1.8%) | 1/80 (1.3%) | ||
| Hypokalaemia | 4/109 (3.7%) | 2/80 (2.5%) | ||
| Hypophosphataemia | 1/109 (0.9%) | 0/80 (0%) | ||
| Impaired Fasting Glucose | 1/109 (0.9%) | 0/80 (0%) | ||
| Increased Appetite | 2/109 (1.8%) | 1/80 (1.3%) | ||
| Type 2 Diabetes Mellitus | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Vitamin D Deficiency | 4/109 (3.7%) | 5/80 (6.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Back Pain | 5/109 (4.6%) | 0/80 (0%) | ||
| Cervical Spinal Stenosis | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Flank Pain | 1/109 (0.9%) | 0/80 (0%) | ||
| Groin Pain | 1/109 (0.9%) | 0/80 (0%) | ||
| Musculoskeletal Pain | 2/109 (1.8%) | 0/80 (0%) | ||
| Musculoskeletal Stiffness | 1/109 (0.9%) | 0/80 (0%) | ||
| Myalgia | 1/109 (0.9%) | 0/80 (0%) | ||
| Pain in Extremity | 1/109 (0.9%) | 4/80 (5%) | ||
| Plantar Fasciitis | 1/109 (0.9%) | 0/80 (0%) | ||
| Systemic Lupus Erythematosus | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Tendonitis | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Tenosynovitis Stenosans | 1/109 (0.9%) | 0/80 (0%) | ||
| Trigger Finger | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adrenal Adenoma | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Seborrhoeic Keratosis | 1/109 (0.9%) | 0/80 (0%) | ||
| Vulvovaginal Warts | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Nervous system disorders | ||||
| Dizziness | 2/109 (1.8%) | 0/80 (0%) | ||
| Headache | 10/109 (9.2%) | 0/80 (0%) | ||
| Hypoaesthesia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Paraesthesia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Seizure | 1/109 (0.9%) | 0/80 (0%) | ||
| Somnolence | 1/109 (0.9%) | 0/80 (0%) | ||
| Syncope | 0/109 (0%) | 1/80 (1.3%) | ||
| Psychiatric disorders | ||||
| Abnormal Dreams | 2/109 (1.8%) | 1/80 (1.3%) | ||
| Adjustment Disorder | 1/109 (0.9%) | 0/80 (0%) | ||
| Adjustment Disorder with Depressed Mood | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Adjustment Disorder with Mixed Anxiety and Depressed Mood | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Alcoholic Hangover | 1/109 (0.9%) | 0/80 (0%) | ||
| Anxiety | 3/109 (2.8%) | 0/80 (0%) | ||
| Bipolar Disorder | 2/109 (1.8%) | 1/80 (1.3%) | ||
| Depressed Mood | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Depression | 2/109 (1.8%) | 3/80 (3.8%) | ||
| Drug Abuse | 2/109 (1.8%) | 2/80 (2.5%) | ||
| Initial Insomnia | 1/109 (0.9%) | 0/80 (0%) | ||
| Insomnia | 5/109 (4.6%) | 2/80 (2.5%) | ||
| Major Depression | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Mental Status Changes | 1/109 (0.9%) | 0/80 (0%) | ||
| Panic Disorder | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Psychotic Disorder | 1/109 (0.9%) | 0/80 (0%) | ||
| Renal and urinary disorders | ||||
| Dysuria | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Reproductive system and breast disorders | ||||
| Cervical Dysplasia | 3/109 (2.8%) | 2/80 (2.5%) | ||
| Erectile Dysfunction | 3/109 (2.8%) | 3/80 (3.8%) | ||
| Gynaecomastia | 1/109 (0.9%) | 0/80 (0%) | ||
| Breast mass | 0/109 (0%) | 1/80 (1.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/109 (0.9%) | 0/80 (0%) | ||
| Cough | 5/109 (4.6%) | 1/80 (1.3%) | ||
| Nasal Congestion | 2/109 (1.8%) | 0/80 (0%) | ||
| Oropharyngeal Pain | 3/109 (2.8%) | 1/80 (1.3%) | ||
| Productive Cough | 1/109 (0.9%) | 0/80 (0%) | ||
| Pulmonary Congestion | 1/109 (0.9%) | 0/80 (0%) | ||
| Rhinitis Allergic | 1/109 (0.9%) | 0/80 (0%) | ||
| Rhinorrhoea | 2/109 (1.8%) | 0/80 (0%) | ||
| Sinus Congestion | 2/109 (1.8%) | 0/80 (0%) | ||
| Dyspnoea | 0/109 (0%) | 1/80 (1.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Alopecia | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Dermal Cyst | 1/109 (0.9%) | 0/80 (0%) | ||
| Dermatitis | 4/109 (3.7%) | 1/80 (1.3%) | ||
| Dermatitis Allergic | 1/109 (0.9%) | 0/80 (0%) | ||
| Dermatitis Contact | 1/109 (0.9%) | 0/80 (0%) | ||
| Dry Skin | 1/109 (0.9%) | 0/80 (0%) | ||
| Eczema | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Macule | 1/109 (0.9%) | 0/80 (0%) | ||
| Night Sweats | 1/109 (0.9%) | 0/80 (0%) | ||
| Pityriasis Rosea | 1/109 (0.9%) | 0/80 (0%) | ||
| Pruritus | 1/109 (0.9%) | 0/80 (0%) | ||
| Rash | 4/109 (3.7%) | 1/80 (1.3%) | ||
| Rash Macular | 2/109 (1.8%) | 0/80 (0%) | ||
| Rash Maculo-Papular | 2/109 (1.8%) | 0/80 (0%) | ||
| Rash Papular | 1/109 (0.9%) | 0/80 (0%) | ||
| Rash Pruritic | 1/109 (0.9%) | 0/80 (0%) | ||
| Seborrhoea | 2/109 (1.8%) | 1/80 (1.3%) | ||
| Skin Disorder | 1/109 (0.9%) | 0/80 (0%) | ||
| Skin Hypopigmentation | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Skin exfoliation | 0/109 (0%) | 1/80 (1.3%) | ||
| Vascular disorders | ||||
| Diastolic Hypertension | 1/109 (0.9%) | 0/80 (0%) | ||
| Essential Hypertension | 1/109 (0.9%) | 1/80 (1.3%) | ||
| Flushing | 1/109 (0.9%) | 0/80 (0%) | ||
| Hypertension | 8/109 (7.3%) | 3/80 (3.8%) | ||
| Hypotension | 1/109 (0.9%) | 0/80 (0%) | ||
| Systolic Hypertension | 2/109 (1.8%) | 0/80 (0%) | ||
Limitations/Caveats
Study limitations included the open-label, single-arm study design and the small sample size.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
| Name/Title | Senior director medical leader |
|---|---|
| Organization | Janssen Scientific Affairs, LLC |
| Phone | 844-434-4210 |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT03227861
Other Study ID Numbers:
- CR108345
- TMC114FD2HTX3002
First Posted:
Jul 24, 2017
Last Update Posted:
Sep 25, 2020
Last Verified:
Sep 1, 2020