Infection, Human Immunodeficiency Virus
Conditions
Brief summary
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.
Interventions
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Men and non-pregnant women, at least 18 years of age * Antiretroviral treatment-naïve; defined as no current or previous exposure to \> 1 week of an antiretroviral drug * Plasma HIV-1 RNA ≥ 1000 copies/mL * CD4 T-cell count \> 200 cells/mm3
Exclusion criteria
* Resistance or partial resistance to any study drug determined by tests at Screening * Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors * Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV) * Blood tests that indicate normal liver function * Hemoglobin \< 8.0 g/dL, platelets \< 50,000 cells/mm3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm | Week 24 | 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. |
| Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96 | 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). |
| Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Week 24 | 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. |
| Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates | Week 24 | 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. |
| Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 | 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. |
| Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 | 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. |
| Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm | 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 \<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). |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | Up to Week 96 | 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. |
| Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events | Up to Week 96 | The occurrence of new AIDS defining events that is CDC class C events is presented. |
| 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 | 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) | 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 of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795 | 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) | Serial blood samples were collected at indicated time points for intensive PK assessment. |
| Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795 | 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) | Serial blood samples were collected at indicated time points for intensive PK assessment. |
| Change From Baseline in the Percentage of CD4+ T-cells Over Time | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84 | 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. |
Countries
Argentina, Canada, Chile, France, Germany, Italy, Mexico, Poland, South Africa, Spain, United Kingdom, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 52 |
| 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. | 51 |
| 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. | 53 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative reason by sponsor | 39 | 40 | 41 | 39 |
| Overall Study | Adverse Event | 1 | 3 | 5 | 10 |
| Overall Study | Lack of Efficacy | 4 | 4 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 | 1 | 1 |
| Overall Study | Other | 0 | 1 | 1 | 0 |
| Overall Study | Poor/Non-compliance | 1 | 0 | 1 | 0 |
| Overall Study | Reached stopping criteria | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|
| Age, Continuous | 31.8 Years STANDARD_DEVIATION 8.26 | 34.7 Years STANDARD_DEVIATION 11.29 | 35.5 Years STANDARD_DEVIATION 11.34 | 32.9 Years STANDARD_DEVIATION 9.35 | 33.7 Years STANDARD_DEVIATION 10.18 |
| Race/Ethnicity, Customized Race customized American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race customized Black or African American | 8 Participants | 10 Participants | 6 Participants | 9 Participants | 33 Participants |
| Race/Ethnicity, Customized Race customized Unknown | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 14 Participants |
| Race/Ethnicity, Customized Race customized White | 39 Participants | 38 Participants | 41 Participants | 40 Participants | 158 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 7 Participants | 7 Participants | 30 Participants |
| Sex: Female, Male Male | 42 Participants | 44 Participants | 44 Participants | 46 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 52 | 0 / 51 | 0 / 53 |
| other Total, other adverse events | 41 / 50 | 46 / 52 | 45 / 51 | 48 / 53 |
| serious Total, serious adverse events | 3 / 50 | 5 / 52 | 2 / 51 | 5 / 53 |
Outcome results
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.
Time frame: Week 24
Population: mITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | 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 | 38 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | 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 | 43 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | 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 | 42 Participants |
| EFV 600 mg + TDF/FTC | 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 | 41 Participants |
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.
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)
Population: Evaluable PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795 | 34226.751 Hour*nanogram/ milliliter | Geometric Coefficient of Variation 18.73 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795 | 55251.956 Hour*nanogram/ milliliter | Geometric Coefficient of Variation 32.88 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795 | 87128.359 Hour*nanogram/ milliliter | Geometric Coefficient of Variation 20.79 |
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.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Population: mITT Population (observed)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 40, n=41, 42, 41, 43 | 175.9 Cells per microliter | Standard Deviation 235.99 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 72; n=5, 5, 5, 7 | 176.2 Cells per microliter | Standard Deviation 98.5 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 12, n=49, 49, 47, 47 | 110.4 Cells per microliter | Standard Deviation 170.87 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 48, n=40, 41, 39, 43 | 158.3 Cells per microliter | Standard Deviation 228.9 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 8, n=48, 49, 49, 47 | 59.1 Cells per microliter | Standard Deviation 219.64 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 84; n=2, 1, 2, 2 | -4.0 Cells per microliter | Standard Deviation 173.95 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 60; n=22, 23, 19, 20 | 168.4 Cells per microliter | Standard Deviation 148.63 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 32, n=44, 42, 42, 44 | 131.5 Cells per microliter | Standard Deviation 207.69 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 24, n=46, 46, 44, 44 | 94.3 Cells per microliter | Standard Deviation 175 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 4, n=50, 51, 50, 50 | 41.6 Cells per microliter | Standard Deviation 148.92 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 16, n=46, 50, 46, 46 | 90.8 Cells per microliter | Standard Deviation 200.76 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 4, n=50, 51, 50, 50 | 72.9 Cells per microliter | Standard Deviation 167.53 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 16, n=46, 50, 46, 46 | 99.7 Cells per microliter | Standard Deviation 171.16 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 8, n=48, 49, 49, 47 | 81.8 Cells per microliter | Standard Deviation 126.79 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 12, n=49, 49, 47, 47 | 120.0 Cells per microliter | Standard Deviation 178.04 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 60; n=22, 23, 19, 20 | 156.5 Cells per microliter | Standard Deviation 301.91 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 32, n=44, 42, 42, 44 | 103.5 Cells per microliter | Standard Deviation 172.15 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 72; n=5, 5, 5, 7 | 336.8 Cells per microliter | Standard Deviation 329.32 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 24, n=46, 46, 44, 44 | 81.2 Cells per microliter | Standard Deviation 195.39 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 84; n=2, 1, 2, 2 | 203.0 Cells per microliter | — |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 48, n=40, 41, 39, 43 | 152.0 Cells per microliter | Standard Deviation 204.56 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 40, n=41, 42, 41, 43 | 194.4 Cells per microliter | Standard Deviation 235.14 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 24, n=46, 46, 44, 44 | 92.5 Cells per microliter | Standard Deviation 144.04 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 40, n=41, 42, 41, 43 | 167.3 Cells per microliter | Standard Deviation 215.23 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 48, n=40, 41, 39, 43 | 161.4 Cells per microliter | Standard Deviation 221.65 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 60; n=22, 23, 19, 20 | 198.3 Cells per microliter | Standard Deviation 137.51 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 72; n=5, 5, 5, 7 | 240.4 Cells per microliter | Standard Deviation 240.48 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 84; n=2, 1, 2, 2 | 97.0 Cells per microliter | Standard Deviation 285.67 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 4, n=50, 51, 50, 50 | 52.9 Cells per microliter | Standard Deviation 149.54 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 8, n=48, 49, 49, 47 | 88.4 Cells per microliter | Standard Deviation 177.68 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 12, n=49, 49, 47, 47 | 129.7 Cells per microliter | Standard Deviation 175.73 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 16, n=46, 50, 46, 46 | 128.0 Cells per microliter | Standard Deviation 212.09 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 32, n=44, 42, 42, 44 | 99.7 Cells per microliter | Standard Deviation 171.95 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 4, n=50, 51, 50, 50 | 64.7 Cells per microliter | Standard Deviation 145.51 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 32, n=44, 42, 42, 44 | 175.6 Cells per microliter | Standard Deviation 152.48 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 16, n=46, 50, 46, 46 | 140.5 Cells per microliter | Standard Deviation 179.7 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 84; n=2, 1, 2, 2 | 165.5 Cells per microliter | Standard Deviation 70 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 72; n=5, 5, 5, 7 | 209.7 Cells per microliter | Standard Deviation 97.79 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 60; n=22, 23, 19, 20 | 204.7 Cells per microliter | Standard Deviation 154.86 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 24, n=46, 46, 44, 44 | 134.7 Cells per microliter | Standard Deviation 151.7 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 48, n=40, 41, 39, 43 | 232.4 Cells per microliter | Standard Deviation 207.71 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 40, n=41, 42, 41, 43 | 222.5 Cells per microliter | Standard Deviation 191.99 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 12, n=49, 49, 47, 47 | 142.5 Cells per microliter | Standard Deviation 118.39 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time | Week 8, n=48, 49, 49, 47 | 117.4 Cells per microliter | Standard Deviation 230.74 |
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.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Population: mITT Population (observed)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 60; n=22, 24, 19, 20 | -2.705 Log 10 c/mL | Standard Deviation 0.6379 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 84; n= 2, 1, 2, 2 | -0.993 Log 10 c/mL | Standard Deviation 3.4142 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 40, n=40, 42, 41, 43 | -2.605 Log 10 c/mL | Standard Deviation 0.7096 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 2, n=8, 6, 10, 8 | -1.927 Log 10 c/mL | Standard Deviation 0.3726 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 48, n=40, 42, 40, 43 | -2.650 Log 10 c/mL | Standard Deviation 0.6824 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 8, n=49, 51, 49, 48 | -2.308 Log 10 c/mL | Standard Deviation 0.6989 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 12, n=49, 50, 47, 47 | -2.372 Log 10 c/mL | Standard Deviation 0.8215 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 4, n=50, 51, 51, 50 | -2.083 Log 10 c/mL | Standard Deviation 0.587 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 72; n=5, 5, 5, 6 | -2.586 Log 10 c/mL | Standard Deviation 0.4682 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 16, n=47, 50, 46, 46 | -2.502 Log 10 c/mL | Standard Deviation 0.865 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 24, n=46, 47, 45, 44 | -2.506 Log 10 c/mL | Standard Deviation 0.8094 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 32, n=44, 42, 42, 44 | -2.497 Log 10 c/mL | Standard Deviation 0.8045 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 4, n=50, 51, 51, 50 | -2.082 Log 10 c/mL | Standard Deviation 0.548 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 32, n=44, 42, 42, 44 | -2.642 Log 10 c/mL | Standard Deviation 0.7408 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 12, n=49, 50, 47, 47 | -2.351 Log 10 c/mL | Standard Deviation 0.7622 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 48, n=40, 42, 40, 43 | -2.649 Log 10 c/mL | Standard Deviation 0.7388 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 60; n=22, 24, 19, 20 | -2.810 Log 10 c/mL | Standard Deviation 0.5765 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 40, n=40, 42, 41, 43 | -2.640 Log 10 c/mL | Standard Deviation 0.7391 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 2, n=8, 6, 10, 8 | -1.930 Log 10 c/mL | Standard Deviation 0.4785 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 24, n=46, 47, 45, 44 | -2.557 Log 10 c/mL | Standard Deviation 0.7956 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 16, n=47, 50, 46, 46 | -2.432 Log 10 c/mL | Standard Deviation 0.7991 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 8, n=49, 51, 49, 48 | -2.262 Log 10 c/mL | Standard Deviation 0.7152 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 84; n= 2, 1, 2, 2 | -3.032 Log 10 c/mL | — |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 72; n=5, 5, 5, 6 | -2.733 Log 10 c/mL | Standard Deviation 0.6809 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 40, n=40, 42, 41, 43 | -2.581 Log 10 c/mL | Standard Deviation 0.6803 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 2, n=8, 6, 10, 8 | -2.006 Log 10 c/mL | Standard Deviation 0.3783 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 4, n=50, 51, 51, 50 | -2.142 Log 10 c/mL | Standard Deviation 0.5092 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 8, n=49, 51, 49, 48 | -2.334 Log 10 c/mL | Standard Deviation 0.6046 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 12, n=49, 50, 47, 47 | -2.441 Log 10 c/mL | Standard Deviation 0.6372 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 16, n=47, 50, 46, 46 | -2.513 Log 10 c/mL | Standard Deviation 0.6429 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 24, n=46, 47, 45, 44 | -2.505 Log 10 c/mL | Standard Deviation 0.7284 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 32, n=44, 42, 42, 44 | -2.528 Log 10 c/mL | Standard Deviation 0.7392 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 48, n=40, 42, 40, 43 | -2.557 Log 10 c/mL | Standard Deviation 0.6711 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 60; n=22, 24, 19, 20 | -2.703 Log 10 c/mL | Standard Deviation 0.7455 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 72; n=5, 5, 5, 6 | -2.725 Log 10 c/mL | Standard Deviation 0.5025 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 84; n= 2, 1, 2, 2 | -3.155 Log 10 c/mL | Standard Deviation 0.1218 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 24, n=46, 47, 45, 44 | -2.919 Log 10 c/mL | Standard Deviation 0.7584 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 16, n=47, 50, 46, 46 | -2.862 Log 10 c/mL | Standard Deviation 0.6903 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 2, n=8, 6, 10, 8 | -2.003 Log 10 c/mL | Standard Deviation 0.3662 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 60; n=22, 24, 19, 20 | -2.906 Log 10 c/mL | Standard Deviation 0.5646 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 12, n=49, 50, 47, 47 | -2.730 Log 10 c/mL | Standard Deviation 0.6254 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 8, n=49, 51, 49, 48 | -2.516 Log 10 c/mL | Standard Deviation 0.6408 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 84; n= 2, 1, 2, 2 | -3.257 Log 10 c/mL | Standard Deviation 0.57 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 72; n=5, 5, 5, 6 | -2.780 Log 10 c/mL | Standard Deviation 0.6598 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 40, n=40, 42, 41, 43 | -2.949 Log 10 c/mL | Standard Deviation 0.7665 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 32, n=44, 42, 42, 44 | -2.920 Log 10 c/mL | Standard Deviation 0.7488 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 4, n=50, 51, 51, 50 | -2.305 Log 10 c/mL | Standard Deviation 0.4554 |
| EFV 600 mg + TDF/FTC | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time | Week 48, n=40, 42, 40, 43 | -2.935 Log 10 c/mL | Standard Deviation 0.7415 |
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.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Population: mITT Population (observed)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 40, n=41, 42, 41, 43 | 7.90 Percentage of CD4+T- cells | Standard Deviation 6.612 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 16, n=46, 50, 46, 46 | 6.20 Percentage of CD4+T- cells | Standard Deviation 6.163 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 48, n=40, 41, 39, 43 | 9.07 Percentage of CD4+T- cells | Standard Deviation 6.311 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 60; n=22, 23, 19, 20 | 9.41 Percentage of CD4+T- cells | Standard Deviation 6.29 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 72; n=5, 5, 5, 7 | 8.56 Percentage of CD4+T- cells | Standard Deviation 3.436 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 24, n=46, 46, 44, 44 | 7.68 Percentage of CD4+T- cells | Standard Deviation 5.834 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 12, n=49, 49, 47, 47 | 5.47 Percentage of CD4+T- cells | Standard Deviation 4.57 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 8, n=48, 49, 49, 47 | 5.02 Percentage of CD4+T- cells | Standard Deviation 4.65 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 4, n=50, 51, 50, 50 | 4.56 Percentage of CD4+T- cells | Standard Deviation 3.195 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 32, n=44, 42, 42, 44 | 7.75 Percentage of CD4+T- cells | Standard Deviation 6.559 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 84; n=2, 1, 2, 2 | -0.75 Percentage of CD4+T- cells | Standard Deviation 8.839 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 32, n=44, 42, 42, 44 | 7.36 Percentage of CD4+T- cells | Standard Deviation 5.457 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 40, n=41, 42, 41, 43 | 6.97 Percentage of CD4+T- cells | Standard Deviation 8.253 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 48, n=40, 41, 39, 43 | 7.62 Percentage of CD4+T- cells | Standard Deviation 6.218 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 8, n=48, 49, 49, 47 | 4.15 Percentage of CD4+T- cells | Standard Deviation 4.047 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 12, n=49, 49, 47, 47 | 5.39 Percentage of CD4+T- cells | Standard Deviation 4.577 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 72; n=5, 5, 5, 7 | 9.92 Percentage of CD4+T- cells | Standard Deviation 4.147 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 16, n=46, 50, 46, 46 | 5.65 Percentage of CD4+T- cells | Standard Deviation 4.179 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 4, n=50, 51, 50, 50 | 3.43 Percentage of CD4+T- cells | Standard Deviation 3.982 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 24, n=46, 46, 44, 44 | 5.71 Percentage of CD4+T- cells | Standard Deviation 4.542 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 84; n=2, 1, 2, 2 | 4.60 Percentage of CD4+T- cells | — |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 60; n=22, 23, 19, 20 | 8.44 Percentage of CD4+T- cells | Standard Deviation 7.788 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 72; n=5, 5, 5, 7 | 12.46 Percentage of CD4+T- cells | Standard Deviation 9.557 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 4, n=50, 51, 50, 50 | 3.93 Percentage of CD4+T- cells | Standard Deviation 3.21 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 12, n=49, 49, 47, 47 | 6.22 Percentage of CD4+T- cells | Standard Deviation 4.45 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 16, n=46, 50, 46, 46 | 6.95 Percentage of CD4+T- cells | Standard Deviation 4.019 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 24, n=46, 46, 44, 44 | 6.96 Percentage of CD4+T- cells | Standard Deviation 4.761 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 32, n=44, 42, 42, 44 | 6.90 Percentage of CD4+T- cells | Standard Deviation 6.498 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 40, n=41, 42, 41, 43 | 7.94 Percentage of CD4+T- cells | Standard Deviation 5.601 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 48, n=40, 41, 39, 43 | 9.59 Percentage of CD4+T- cells | Standard Deviation 4.828 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 60; n=22, 23, 19, 20 | 11.36 Percentage of CD4+T- cells | Standard Deviation 6.568 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 8, n=48, 49, 49, 47 | 5.15 Percentage of CD4+T- cells | Standard Deviation 3.943 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 84; n=2, 1, 2, 2 | 19.50 Percentage of CD4+T- cells | Standard Deviation 11.314 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 24, n=46, 46, 44, 44 | 5.94 Percentage of CD4+T- cells | Standard Deviation 5.73 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 8, n=48, 49, 49, 47 | 5.09 Percentage of CD4+T- cells | Standard Deviation 4.257 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 60; n=22, 23, 19, 20 | 10.73 Percentage of CD4+T- cells | Standard Deviation 7.098 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 16, n=46, 50, 46, 46 | 6.87 Percentage of CD4+T- cells | Standard Deviation 4.763 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 12, n=49, 49, 47, 47 | 6.29 Percentage of CD4+T- cells | Standard Deviation 4.557 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 84; n=2, 1, 2, 2 | 12.90 Percentage of CD4+T- cells | Standard Deviation 4.95 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 72; n=5, 5, 5, 7 | 9.67 Percentage of CD4+T- cells | Standard Deviation 3.982 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 40, n=41, 42, 41, 43 | 9.06 Percentage of CD4+T- cells | Standard Deviation 5.538 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 4, n=50, 51, 50, 50 | 3.87 Percentage of CD4+T- cells | Standard Deviation 4.284 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 48, n=40, 41, 39, 43 | 10.16 Percentage of CD4+T- cells | Standard Deviation 6.262 |
| EFV 600 mg + TDF/FTC | Change From Baseline in the Percentage of CD4+ T-cells Over Time | Week 32, n=44, 42, 42, 44 | 8.37 Percentage of CD4+T- cells | Standard Deviation 6.253 |
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.
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)
Population: Evaluable PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | 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 | C0 | 1065.102 Nanogram per milliliter | Geometric Coefficient of Variation 25.2 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | 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 | Cmax | 1945.342 Nanogram per milliliter | Geometric Coefficient of Variation 16 |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | 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 | Ctau | 1100.138 Nanogram per milliliter | Geometric Coefficient of Variation 15.1 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | 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 | C0 | 1800.952 Nanogram per milliliter | Geometric Coefficient of Variation 33.4 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | 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 | Cmax | 3162.161 Nanogram per milliliter | Geometric Coefficient of Variation 28.8 |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | 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 | Ctau | 1656.578 Nanogram per milliliter | Geometric Coefficient of Variation 39.7 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | 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 | Cmax | 4645.266 Nanogram per milliliter | Geometric Coefficient of Variation 16.2 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | 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 | Ctau | 2705.751 Nanogram per milliliter | Geometric Coefficient of Variation 26.8 |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | 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 | C0 | 2728.671 Nanogram per milliliter | Geometric Coefficient of Variation 17.8 |
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.
Time frame: Up to Week 96
Population: mITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events | 0 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events | 2 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events | 0 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events | 0 Participants |
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.
Time frame: Week 24
Population: mITT Population. Only participants with Baseline and on-treatment genotypic resistance testing and who had successful sequencing were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Protease inhibitor substitution | 1 Participants |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Reverse transcriptase substitution | 3 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Reverse transcriptase substitution | 5 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Protease inhibitor substitution | 0 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Protease inhibitor substitution | 0 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Reverse transcriptase substitution | 2 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Protease inhibitor substitution | 0 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates | Reverse transcriptase substitution | 0 Participants |
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.
Time frame: Week 24
Population: mITT Population. Only participants who had Baseline and on-treatment phenotypic resistance testing were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates | 1 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates | 0 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates | 0 Participants |
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.
Time frame: Week 24
Population: mITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm | 40 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm | 44 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm | 43 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm | 44 Participants |
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).
Time frame: Weeks 48 and 96
Population: mITT Population (observed)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96 | Week 48; n=40, 42, 40, 43 | 38 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96 | Week 48; n=40, 42, 40, 43 | 42 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96 | Week 48; n=40, 42, 40, 43 | 40 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96 | Week 48; n=40, 42, 40, 43 | 43 Participants |
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).
Time frame: Weeks 48 and 96
Population: mITT Population (observed)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm | Week 48; n=40, 42, 40, 43 | 35 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm | Week 48; n=40, 42, 40, 43 | 41 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm | Week 48; n=40, 42, 40, 43 | 40 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm | Week 48; n=40, 42, 40, 43 | 40 Participants |
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.
Time frame: Up to Week 96
Population: mITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | SAEs | 3 Participants |
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | AELD | 1 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | AELD | 4 Participants |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | SAEs | 5 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | SAEs | 2 Participants |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | AELD | 5 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | SAEs | 5 Participants |
| EFV 600 mg + TDF/FTC | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) | AELD | 10 Participants |
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.
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)
Population: Evaluable PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BMS-955176/GSK3532795 60 mg + TDF/FTC | Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795 | 4.00 Hour |
| BMS-955176/GSK3532795 120 mg + TDF/FTC | Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795 | 4.29 Hour |
| BMS-955176/GSK3532795 180 mg + TDF/FTC | Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795 | 5.50 Hour |