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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005487-26 | EudraCT Number | ||
| AI468-038 | Other Identifier | Bristol-Myers Squibb |
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The trial ended early due to GI intolerability and treatment-emergent resistance.
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-955176 60 mg + TDF/FTC | Experimental | BMS-955176 at 60 mg active dose per day + BMS-955176 placebo matching 120 mg + efavirenz (EFV) placebo matching 600 mg + tenofovir/emtricitabine (TDF/FTC) 300/200 mg per day, orally |
|
| Arm 2: BMS-955176 120 mg + TDF/FTC | Experimental | BMS-955176 placebo matching 60 mg + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC 300/200mg per day, orally |
|
| Arm 3: BMS-955176 180 mg + TDF/FTC | Experimental | BMS-955176 at 60mg active dose per day + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC at 300/200mg per day, orally |
|
| Arm 4: EFV + TDF/FTC | Active Comparator | BMS-955176 placebo matching 60mg + BMS-955176 placebo matching 120mg + EFV at 600mg per day + TDF/FTC 300/200mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-955176 | Drug | HIV Maturation Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24 Using Food and Drug Administration (FDA) Snapshot Algorithm | Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response. Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm | Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beverly Hills | California | 90211 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30352054 | Derived | Morales-Ramirez J, Bogner JR, Molina JM, Lombaard J, Dicker IB, Stock DA, DeGrosky M, Gartland M, Pene Dumitrescu T, Min S, Llamoso C, Joshi SR, Lataillade M. Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial. PLoS One. 2018 Oct 23;13(10):e0205368. doi: 10.1371/journal.pone.0205368. eCollection 2018. |
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A total of 305 participants were screened, of which 210 were randomized to 1 of 4 treatment arms. Of 210 participants, only 206 received study treatment. Four participants were randomized but not treated as: 2 participants were randomized in error, 1 participant was lost to follow-up and 1 participant withdrew consent.
This study was originally designed for 96 weeks of treatment in treatment naïve human immunodeficiency virus-1 (HIV-1) infected adults; however, it was terminated early due to gastrointestinal intolerability and treatment emergent resistance. The study was conducted at 58 centers in 12 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BMS-955176/GSK3532795 60 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| EFV | Drug | EFV |
|
| TDF/FTC | Drug | TDF/FTC |
|
| Weeks 48 and 96 |
| Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm | Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. | Week 24 |
| Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96 | Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | Weeks 48 and 96 |
| Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing. | Week 24 |
| Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates | Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50<= 3 and an on-treatment fold change IC50>3. The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. | Week 24 |
| Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Blood samples were collected for analysis of HIV-1 RNA. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 |
| Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | CD4+ T-cell counts was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 |
| Change From Baseline in the Percentage of CD4+ T-cells Over Time | CD4+ T-cell counts overall was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with SAEs and AELDs is summarized. | Up to Week 96 |
| Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events | The occurrence of new AIDS defining events that is CDC class C events is presented. | Up to Week 96 |
| Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795 | Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment. The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles. | Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16) |
| Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795 | Serial blood samples were collected at indicated time points for intensive PK assessment. | Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16) |
| Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795 | Serial blood samples were collected at indicated time points for intensive PK assessment. | Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16) |
| Los Angeles |
| California |
| 90036 |
| United States |
| GSK Investigational Site | DeLand | Florida | 32720 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30312 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Santa Fe | New Mexico | 87505 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74135 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| GSK Investigational Site | Rosario | Santa Fe Province | 2000 | Argentina |
| GSK Investigational Site | Buenos Aires | 1141 | Argentina |
| GSK Investigational Site | Buenos Aires | 1202 | Argentina |
| GSK Investigational Site | Córdoba | X5000JJS | Argentina |
| GSK Investigational Site | Edmonton | Alberta | T6G 2G3 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 5B1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3A 1T1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4A 3J1 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Santiago | Región Metro de Santiago | Chile |
| GSK Investigational Site | Santiago | 7560994 | Chile |
| GSK Investigational Site | Santiago | 8360159 | Chile |
| GSK Investigational Site | Le Kremlin-Bicêtre | 94276 | France |
| GSK Investigational Site | Lyon | 69317 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Nice | 06202 | France |
| GSK Investigational Site | Paris | 75012 | France |
| GSK Investigational Site | Paris | 75013 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Munich | Bavaria | 80335 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80336 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53127 | Germany |
| GSK Investigational Site | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| GSK Investigational Site | Berlin | 12157 | Germany |
| GSK Investigational Site | Berlin | 13353 | Germany |
| GSK Investigational Site | Dortmund | 44137 | Germany |
| GSK Investigational Site | Bergamo | Lombardy | 24127 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20157 | Italy |
| GSK Investigational Site | Monza | Lombardy | 20900 | Italy |
| GSK Investigational Site | Fracc. Las Americas | Aguascalientes | 20020 | Mexico |
| GSK Investigational Site | León | Guanajuato | 37000 | Mexico |
| GSK Investigational Site | DF | 14000 | Mexico |
| GSK Investigational Site | Durango | 34000 | Mexico |
| GSK Investigational Site | Mexico City | CP 14080 | Mexico |
| GSK Investigational Site | Bydgoszcz | 85-030 | Poland |
| GSK Investigational Site | Szczecin | 71-252 | Poland |
| GSK Investigational Site | Warsaw | 01-201 | Poland |
| GSK Investigational Site | Wroclaw | 50-220 | Poland |
| GSK Investigational Site | Bloemfontein | Free State | 9301 | South Africa |
| GSK Investigational Site | Alcalá de Henares | 28805 | Spain |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Edinburgh | Midlothian | EH4 2XU | United Kingdom |
| GSK Investigational Site | London | E1 1BB | United Kingdom |
| GSK Investigational Site | London | SW10 9NH | United Kingdom |
| GSK Investigational Site | London | W2 1NY | United Kingdom |
| GSK Investigational Site | Tooting, London | SW17 0QT | United Kingdom |
| FG001 | BMS-955176/GSK3532795 120 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| FG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| FG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics is presented for Treated Subjects Population, also known as the modified intent-to-treat (mITT) Population which comprised of all participants who received at least one dose of BMS-955176 or EFV.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BMS-955176/GSK3532795 60 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96. |
| BG001 | BMS-955176/GSK3532795 120 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| BG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| BG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Treated Subjects Population, also known as the modified intent-to-treat (mITT) population, comprised of all subjects who received at least one dose of study treatment, was used to present baseline characteristics | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24 Using Food and Drug Administration (FDA) Snapshot Algorithm | Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response. Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV. | mITT Population | Posted | Count of Participants | Participants | Week 24 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm | Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | mITT Population (observed) | Posted | Count of Participants | Participants | Weeks 48 and 96 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm | Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. | mITT Population | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96 | Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). | mITT Population (observed) | Posted | Count of Participants | Participants | Weeks 48 and 96 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing. | mITT Population. Only participants with Baseline and on-treatment genotypic resistance testing and who had successful sequencing were analyzed. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates | Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50<= 3 and an on-treatment fold change IC50>3. The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. | mITT Population. Only participants who had Baseline and on-treatment phenotypic resistance testing were analyzed. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Blood samples were collected for analysis of HIV-1 RNA. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. | mITT Population (observed) | Posted | Mean | Standard Deviation | Log 10 c/mL | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 |
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| Secondary | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | CD4+ T-cell counts was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. | mITT Population (observed) | Posted | Mean | Standard Deviation | Cells per microliter | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Percentage of CD4+ T-cells Over Time | CD4+ T-cell counts overall was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. | mITT Population (observed) | Posted | Mean | Standard Deviation | Percentage of CD4+T- cells | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with SAEs and AELDs is summarized. | mITT Population | Posted | Count of Participants | Participants | Up to Week 96 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events | The occurrence of new AIDS defining events that is CDC class C events is presented. | mITT Population | Posted | Count of Participants | Participants | Up to Week 96 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795 | Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment. The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles. | Evaluable PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795 | Serial blood samples were collected at indicated time points for intensive PK assessment. | Evaluable PK Population | Posted | Median | Full Range | Hour | Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795 | Serial blood samples were collected at indicated time points for intensive PK assessment. | Evaluable PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/ milliliter | Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16) |
|
Non-serious adverse events and serious adverse events (SAEs) were collected from the start of study treatment until Week 96.
Non-SAEs and SAEs were collected in the mITT Population, which comprised of all participants who received at least one dose of BMS-955176/GSK3532795 or EFV.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMS-955176/GSK3532795 60 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96. | 0 | 50 | 3 | 50 | 41 | 50 |
| EG001 | BMS-955176/GSK3532795 120 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. | 0 | 52 | 5 | 52 | 46 | 52 |
| EG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. | 0 | 51 | 2 | 51 | 45 | 51 |
| EG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. | 0 | 53 | 5 | 53 | 48 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Orthostatic intolerance | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627567 | BMS-955176 |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Unknown |
|
| OG001 | BMS-955176/GSK3532795 120 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG001 | BMS-955176/GSK3532795 120 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| BMS-955176/GSK3532795 120 mg + TDF/FTC |
Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG001 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC |
Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG001 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC |
Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG001 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC |
Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96. |
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG002 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC |
Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
| OG003 | EFV 600 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
|
| OG002 | BMS-955176/GSK3532795 180 mg + TDF/FTC | Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96. |
|
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