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Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

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ClinicalTrials.gov Identifier: NCT02415595
Recruitment Status : Terminated (The trial ended early due to GI intolerability and treatment-emergent resistance.)
First Posted : April 14, 2015
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus
Interventions Drug: BMS-955176
Drug: EFV
Drug: TDF/FTC
Enrollment 210
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 50 52 51 53
Completed 0 0 0 0
Not Completed 50 52 51 53
Reason Not Completed
Administrative reason by sponsor             39             40             41             39
Adverse Event             1             3             5             10
Lack of Efficacy             4             4             0             0
Lost to Follow-up             1             3             1             1
Poor/Non-compliance             1             0             1             0
Reached stopping criteria             0             1             1             0
Withdrawal by Subject             4             0             1             3
Other             0             1             1             0
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 50 52 51 53 206
Hide Baseline Analysis Population Description
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.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 52 participants 51 participants 53 participants 206 participants
31.8  (8.26) 34.7  (11.29) 35.5  (11.34) 32.9  (9.35) 33.7  (10.18)
[1]
Measure Analysis Population Description: 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 51 participants 53 participants 206 participants
Female
8
  16.0%
8
  15.4%
7
  13.7%
7
  13.2%
30
  14.6%
Male
42
  84.0%
44
  84.6%
44
  86.3%
46
  86.8%
176
  85.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race customized Number Analyzed 50 participants 52 participants 51 participants 53 participants 206 participants
White
39
  78.0%
38
  73.1%
41
  80.4%
40
  75.5%
158
  76.7%
Black or African American
8
  16.0%
10
  19.2%
6
  11.8%
9
  17.0%
33
  16.0%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
1
   0.5%
Unknown
3
   6.0%
4
   7.7%
3
   5.9%
4
   7.5%
14
   6.8%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Measure Type: Count of Participants
Unit of Measure: Participants
38
  76.0%
43
  82.7%
42
  82.4%
41
  77.4%
2.Secondary Outcome
Title Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm
Hide Description 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).
Time Frame Weeks 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed)
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Measure Type: Count of Participants
Unit of Measure: Participants
Week 48; n=40, 42, 40, 43 Number Analyzed 40 participants 42 participants 40 participants 43 participants
35
  87.5%
41
  97.6%
40
 100.0%
40
  93.0%
Week 96; n=0, 0, 0, 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants
3.Secondary Outcome
Title Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Measure Type: Count of Participants
Unit of Measure: Participants
40
  80.0%
44
  84.6%
43
  84.3%
44
  83.0%
4.Secondary Outcome
Title Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96
Hide Description 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).
Time Frame Weeks 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed)
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Measure Type: Count of Participants
Unit of Measure: Participants
Week 48; n=40, 42, 40, 43 Number Analyzed 40 participants 42 participants 40 participants 43 participants
38
  95.0%
42
 100.0%
40
 100.0%
43
 100.0%
Week 96; n=0, 0, 0, 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants
5.Secondary Outcome
Title Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only participants with Baseline and on-treatment genotypic resistance testing and who had successful sequencing were analyzed.
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 5 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
Protease inhibitor substitution
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
Reverse transcriptase substitution
3
  60.0%
5
 100.0%
2
 100.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only participants who had Baseline and on-treatment phenotypic resistance testing were analyzed.
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 3 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
  33.3%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time
Hide Description 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.
Time Frame Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed)
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Mean (Standard Deviation)
Unit of Measure: Log 10 c/mL
Week 2, n=8, 6, 10, 8 Number Analyzed 8 participants 6 participants 10 participants 8 participants
-1.927  (0.3726) -1.930  (0.4785) -2.006  (0.3783) -2.003  (0.3662)
Week 4, n=50, 51, 51, 50 Number Analyzed 50 participants 51 participants 51 participants 50 participants
-2.083  (0.5870) -2.082  (0.5480) -2.142  (0.5092) -2.305  (0.4554)
Week 8, n=49, 51, 49, 48 Number Analyzed 49 participants 51 participants 49 participants 48 participants
-2.308  (0.6989) -2.262  (0.7152) -2.334  (0.6046) -2.516  (0.6408)
Week 12, n=49, 50, 47, 47 Number Analyzed 49 participants 50 participants 47 participants 47 participants
-2.372  (0.8215) -2.351  (0.7622) -2.441  (0.6372) -2.730  (0.6254)
Week 16, n=47, 50, 46, 46 Number Analyzed 47 participants 50 participants 46 participants 46 participants
-2.502  (0.8650) -2.432  (0.7991) -2.513  (0.6429) -2.862  (0.6903)
Week 24, n=46, 47, 45, 44 Number Analyzed 46 participants 47 participants 45 participants 44 participants
-2.506  (0.8094) -2.557  (0.7956) -2.505  (0.7284) -2.919  (0.7584)
Week 32, n=44, 42, 42, 44 Number Analyzed 44 participants 42 participants 42 participants 44 participants
-2.497  (0.8045) -2.642  (0.7408) -2.528  (0.7392) -2.920  (0.7488)
Week 40, n=40, 42, 41, 43 Number Analyzed 40 participants 42 participants 41 participants 43 participants
-2.605  (0.7096) -2.640  (0.7391) -2.581  (0.6803) -2.949  (0.7665)
Week 48, n=40, 42, 40, 43 Number Analyzed 40 participants 42 participants 40 participants 43 participants
-2.650  (0.6824) -2.649  (0.7388) -2.557  (0.6711) -2.935  (0.7415)
Week 60; n=22, 24, 19, 20 Number Analyzed 22 participants 24 participants 19 participants 20 participants
-2.705  (0.6379) -2.810  (0.5765) -2.703  (0.7455) -2.906  (0.5646)
Week 72; n=5, 5, 5, 6 Number Analyzed 5 participants 5 participants 5 participants 6 participants
-2.586  (0.4682) -2.733  (0.6809) -2.725  (0.5025) -2.780  (0.6598)
Week 84; n= 2, 1, 2, 2 Number Analyzed 2 participants 1 participants 2 participants 2 participants
-0.993  (3.4142) -3.032 [1]   (NA) -3.155  (0.1218) -3.257  (0.5700)
[1]
Standard deviation could not be calculated as only one participant was analyzed.
8.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time
Hide Description 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.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed)
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Mean (Standard Deviation)
Unit of Measure: Cells per microliter
Week 4, n=50, 51, 50, 50 Number Analyzed 50 participants 51 participants 50 participants 50 participants
41.6  (148.92) 72.9  (167.53) 52.9  (149.54) 64.7  (145.51)
Week 8, n=48, 49, 49, 47 Number Analyzed 48 participants 49 participants 49 participants 47 participants
59.1  (219.64) 81.8  (126.79) 88.4  (177.68) 117.4  (230.74)
Week 12, n=49, 49, 47, 47 Number Analyzed 49 participants 49 participants 47 participants 47 participants
110.4  (170.87) 120.0  (178.04) 129.7  (175.73) 142.5  (118.39)
Week 16, n=46, 50, 46, 46 Number Analyzed 46 participants 50 participants 46 participants 46 participants
90.8  (200.76) 99.7  (171.16) 128.0  (212.09) 140.5  (179.70)
Week 24, n=46, 46, 44, 44 Number Analyzed 46 participants 46 participants 44 participants 44 participants
94.3  (175.00) 81.2  (195.39) 92.5  (144.04) 134.7  (151.70)
Week 32, n=44, 42, 42, 44 Number Analyzed 44 participants 42 participants 42 participants 44 participants
131.5  (207.69) 103.5  (172.15) 99.7  (171.95) 175.6  (152.48)
Week 40, n=41, 42, 41, 43 Number Analyzed 41 participants 42 participants 41 participants 43 participants
175.9  (235.99) 194.4  (235.14) 167.3  (215.23) 222.5  (191.99)
Week 48, n=40, 41, 39, 43 Number Analyzed 40 participants 41 participants 39 participants 43 participants
158.3  (228.90) 152.0  (204.56) 161.4  (221.65) 232.4  (207.71)
Week 60; n=22, 23, 19, 20 Number Analyzed 22 participants 23 participants 19 participants 20 participants
168.4  (148.63) 156.5  (301.91) 198.3  (137.51) 204.7  (154.86)
Week 72; n=5, 5, 5, 7 Number Analyzed 5 participants 5 participants 5 participants 7 participants
176.2  (98.50) 336.8  (329.32) 240.4  (240.48) 209.7  (97.79)
Week 84; n=2, 1, 2, 2 Number Analyzed 2 participants 1 participants 2 participants 2 participants
-4.0  (173.95) 203.0 [1]   (NA) 97.0  (285.67) 165.5  (70.00)
[1]
Standard deviation could not be calculated as only one participant was analyzed.
9.Secondary Outcome
Title Change From Baseline in the Percentage of CD4+ T-cells Over Time
Hide Description 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.
Time Frame Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed)
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Mean (Standard Deviation)
Unit of Measure: Percentage of CD4+T- cells
Week 4, n=50, 51, 50, 50 Number Analyzed 50 participants 51 participants 50 participants 50 participants
4.56  (3.195) 3.43  (3.982) 3.93  (3.210) 3.87  (4.284)
Week 8, n=48, 49, 49, 47 Number Analyzed 48 participants 49 participants 49 participants 47 participants
5.02  (4.650) 4.15  (4.047) 5.15  (3.943) 5.09  (4.257)
Week 12, n=49, 49, 47, 47 Number Analyzed 49 participants 49 participants 47 participants 47 participants
5.47  (4.570) 5.39  (4.577) 6.22  (4.450) 6.29  (4.557)
Week 16, n=46, 50, 46, 46 Number Analyzed 46 participants 50 participants 46 participants 46 participants
6.20  (6.163) 5.65  (4.179) 6.95  (4.019) 6.87  (4.763)
Week 24, n=46, 46, 44, 44 Number Analyzed 46 participants 46 participants 44 participants 44 participants
7.68  (5.834) 5.71  (4.542) 6.96  (4.761) 5.94  (5.730)
Week 32, n=44, 42, 42, 44 Number Analyzed 44 participants 42 participants 42 participants 44 participants
7.75  (6.559) 7.36  (5.457) 6.90  (6.498) 8.37  (6.253)
Week 40, n=41, 42, 41, 43 Number Analyzed 41 participants 42 participants 41 participants 43 participants
7.90  (6.612) 6.97  (8.253) 7.94  (5.601) 9.06  (5.538)
Week 48, n=40, 41, 39, 43 Number Analyzed 40 participants 41 participants 39 participants 43 participants
9.07  (6.311) 7.62  (6.218) 9.59  (4.828) 10.16  (6.262)
Week 60; n=22, 23, 19, 20 Number Analyzed 22 participants 23 participants 19 participants 20 participants
9.41  (6.290) 8.44  (7.788) 11.36  (6.568) 10.73  (7.098)
Week 72; n=5, 5, 5, 7 Number Analyzed 5 participants 5 participants 5 participants 7 participants
8.56  (3.436) 9.92  (4.147) 12.46  (9.557) 9.67  (3.982)
Week 84; n=2, 1, 2, 2 Number Analyzed 2 participants 1 participants 2 participants 2 participants
-0.75  (8.839) 4.60 [1]   (NA) 19.50  (11.314) 12.90  (4.950)
[1]
Standard deviation could not be analyzed as only one participant was analyzed.
10.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD)
Hide Description 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.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs
3
   6.0%
5
   9.6%
2
   3.9%
5
   9.4%
AELD
1
   2.0%
4
   7.7%
5
   9.8%
10
  18.9%
11.Secondary Outcome
Title Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events
Hide Description The occurrence of new AIDS defining events that is CDC class C events is presented.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 50 52 51 53
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   3.8%
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable PK Population
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 8 6 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
Cmax
1945.342
(16.0%)
3162.161
(28.8%)
4645.266
(16.2%)
C0
1065.102
(25.2%)
1800.952
(33.4%)
2728.671
(17.8%)
Ctau
1100.138
(15.1%)
1656.578
(39.7%)
2705.751
(26.8%)
13.Secondary Outcome
Title Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795
Hide Description Serial blood samples were collected at indicated time points for intensive PK assessment.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable PK Population
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 8 6 10
Median (Full Range)
Unit of Measure: Hour
4.00
(1.6 to 8.2)
4.29
(4.0 to 5.1)
5.50
(1.0 to 12.0)
14.Secondary Outcome
Title Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795
Hide Description Serial blood samples were collected at indicated time points for intensive PK assessment.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable PK Population
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 8 6 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*nanogram/ milliliter
34226.751
(18.73%)
55251.956
(32.88%)
87128.359
(20.79%)
Time Frame Non-serious adverse events and serious adverse events (SAEs) were collected from the start of study treatment until Week 96.
Adverse Event Reporting Description 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.
 
Arm/Group Title BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/52 (0.00%)      0/51 (0.00%)      0/53 (0.00%)    
Hide Serious Adverse Events
BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/50 (6.00%)      5/52 (9.62%)      2/51 (3.92%)      5/53 (9.43%)    
Cardiac disorders         
Ventricular extrasystoles  1  0/50 (0.00%)  0 0/52 (0.00%)  0 0/51 (0.00%)  0 1/53 (1.89%)  1
Gastrointestinal disorders         
Abdominal pain  1  0/50 (0.00%)  0 1/52 (1.92%)  1 0/51 (0.00%)  0 0/53 (0.00%)  0
Colitis ulcerative  1  1/50 (2.00%)  1 0/52 (0.00%)  0 0/51 (0.00%)  0 0/53 (0.00%)  0
Toothache  1  0/50 (0.00%)  0 0/52 (0.00%)  0 0/51 (0.00%)  0 1/53 (1.89%)  1
Infections and infestations         
Appendicitis  1  0/50 (0.00%)  0 1/52 (1.92%)  1 0/51 (0.00%)  0 0/53 (0.00%)  0
Intervertebral discitis  1  0/50 (0.00%)  0 0/52 (0.00%)  0 1/51 (1.96%)  1 0/53 (0.00%)  0
Metapneumovirus infection  1  0/50 (0.00%)  0 0/52 (0.00%)  0 1/51 (1.96%)  1 0/53 (0.00%)  0
Pelvic infection  1  0/50 (0.00%)  0 1/52 (1.92%)  1 0/51 (0.00%)  0 0/53 (0.00%)  0
Urinary tract infection  1  0/50 (0.00%)  0 0/52 (0.00%)  0 0/51 (0.00%)  0 1/53 (1.89%)  1
Injury, poisoning and procedural complications         
Gastrointestinal injury  1  1/50 (2.00%)  1 0/52 (0.00%)  0 0/51 (0.00%)  0 0/53 (0.00%)  0
Overdose  1  0/50 (0.00%)  0 1/52 (1.92%)  1 0/51 (0.00%)  0 0/53 (0.00%)  0
Investigations         
Hepatic enzyme increased  1  0/50 (0.00%)  0 0/52 (0.00%)  0 0/51 (0.00%)  0 1/53 (1.89%)  1
Musculoskeletal and connective tissue disorders         
Osteonecrosis  1  0/50 (0.00%)  0 1/52 (1.92%)  1 0/51 (0.00%)  0 0/53 (0.00%)  0
Nervous system disorders         
Orthostatic intolerance  1  1/50 (2.00%)  1 0/52 (0.00%)  0 0/51 (0.00%)  0 0/53 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury  1  0/50 (0.00%)  0 0/52 (0.00%)  0 1/51 (1.96%)  1 0/53 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pneumothorax spontaneous  1  0/50 (0.00%)  0 0/52 (0.00%)  0 0/51 (0.00%)  0 1/53 (1.89%)  1
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/50 (82.00%)      46/52 (88.46%)      45/51 (88.24%)      48/53 (90.57%)    
Ear and labyrinth disorders         
Vertigo  1  1/50 (2.00%)  1 0/52 (0.00%)  0 0/51 (0.00%)  0 4/53 (7.55%)  4
Gastrointestinal disorders         
Abdominal distension  1  0/50 (0.00%)  0 0/52 (0.00%)  0 3/51 (5.88%)  3 0/53 (0.00%)  0
Abdominal pain  1  5/50 (10.00%)  6 6/52 (11.54%)  8 10/51 (19.61%)  14 1/53 (1.89%)  1
Abdominal pain upper  1  3/50 (6.00%)  4 3/52 (5.77%)  5 4/51 (7.84%)  5 0/53 (0.00%)  0
Diarrhoea  1  20/50 (40.00%)  30 22/52 (42.31%)  33 31/51 (60.78%)  58 8/53 (15.09%)  9
Dyspepsia  1  0/50 (0.00%)  0 5/52 (9.62%)  6 2/51 (3.92%)  2 0/53 (0.00%)  0
Irritable bowel syndrome  1  0/50 (0.00%)  0 1/52 (1.92%)  1 3/51 (5.88%)  3 0/53 (0.00%)  0
Nausea  1  4/50 (8.00%)  4 4/52 (7.69%)  4 6/51 (11.76%)  7 7/53 (13.21%)  8
Toothache  1  1/50 (2.00%)  1 1/52 (1.92%)  1 0/51 (0.00%)  0 3/53 (5.66%)  3
Vomiting  1  2/50 (4.00%)  2 5/52 (9.62%)  6 3/51 (5.88%)  4 2/53 (3.77%)  2
General disorders         
Fatigue  1  3/50 (6.00%)  3 1/52 (1.92%)  1 3/51 (5.88%)  3 2/53 (3.77%)  2
Pyrexia  1  2/50 (4.00%)  2 0/52 (0.00%)  0 4/51 (7.84%)  4 2/53 (3.77%)  2
Infections and infestations         
Bronchitis  1  2/50 (4.00%)  2 4/52 (7.69%)  5 0/51 (0.00%)  0 1/53 (1.89%)  1
Conjunctivitis  1  3/50 (6.00%)  3 0/52 (0.00%)  0 1/51 (1.96%)  1 2/53 (3.77%)  2
Influenza  1  1/50 (2.00%)  1 6/52 (11.54%)  6 1/51 (1.96%)  1 3/53 (5.66%)  4
Nasopharyngitis  1  5/50 (10.00%)  8 4/52 (7.69%)  5 6/51 (11.76%)  8 4/53 (7.55%)  4
Pharyngitis  1  6/50 (12.00%)  7 3/52 (5.77%)  4 2/51 (3.92%)  4 3/53 (5.66%)  4
Sinusitis  1  4/50 (8.00%)  5 1/52 (1.92%)  1 1/51 (1.96%)  1 1/53 (1.89%)  1
Upper respiratory tract infection  1  3/50 (6.00%)  7 8/52 (15.38%)  11 6/51 (11.76%)  8 1/53 (1.89%)  2
Urethritis  1  4/50 (8.00%)  5 1/52 (1.92%)  1 0/51 (0.00%)  0 0/53 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  2/50 (4.00%)  2 1/52 (1.92%)  1 3/51 (5.88%)  3 1/53 (1.89%)  1
Muscle spasms  1  2/50 (4.00%)  2 1/52 (1.92%)  1 3/51 (5.88%)  3 0/53 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anogenital warts  1  0/50 (0.00%)  0 3/52 (5.77%)  3 0/51 (0.00%)  0 1/53 (1.89%)  1
Nervous system disorders         
Dizziness  1  0/50 (0.00%)  0 2/52 (3.85%)  2 2/51 (3.92%)  2 21/53 (39.62%)  27
Headache  1  1/50 (2.00%)  1 6/52 (11.54%)  8 7/51 (13.73%)  8 6/53 (11.32%)  8
Psychiatric disorders         
Abnormal dreams  1  1/50 (2.00%)  1 4/52 (7.69%)  5 1/51 (1.96%)  1 6/53 (11.32%)  6
Anxiety  1  1/50 (2.00%)  1 1/52 (1.92%)  1 1/51 (1.96%)  1 4/53 (7.55%)  4
Insomnia  1  1/50 (2.00%)  3 1/52 (1.92%)  1 7/51 (13.73%)  9 3/53 (5.66%)  3
Reproductive system and breast disorders         
Erectile dysfunction  1  0/50 (0.00%)  0 0/52 (0.00%)  0 3/51 (5.88%)  3 0/53 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/50 (2.00%)  1 3/52 (5.77%)  3 1/51 (1.96%)  1 0/53 (0.00%)  0
Oropharyngeal pain  1  3/50 (6.00%)  3 1/52 (1.92%)  1 1/51 (1.96%)  1 3/53 (5.66%)  3
Skin and subcutaneous tissue disorders         
Dermatitis allergic  1  1/50 (2.00%)  1 0/52 (0.00%)  0 0/51 (0.00%)  0 3/53 (5.66%)  3
Drug eruption  1  0/50 (0.00%)  0 0/52 (0.00%)  0 1/51 (1.96%)  1 3/53 (5.66%)  3
Pruritus  1  3/50 (6.00%)  3 1/52 (1.92%)  1 0/51 (0.00%)  0 1/53 (1.89%)  1
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02415595    
Other Study ID Numbers: 205891
2013-005487-26 ( EudraCT Number )
AI468-038 ( Other Identifier: Bristol-Myers Squibb )
First Submitted: March 11, 2015
First Posted: April 14, 2015
Results First Submitted: August 20, 2018
Results First Posted: September 19, 2018
Last Update Posted: September 19, 2018