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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004124-38 | EudraCT Number | ||
| AI468-002 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients
Masking: Open-Part B. Double Blind-Parts A and C
Gender: Both female and male participants for Parts A and C. Male participants for Part B.
HIV = Human Immunodeficiency Virus RNA = Ribonucleic acid
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) or Placebo | Experimental | BMS-955176 5 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days |
|
| Part A-Group 2: BMS-955176 (10 mg) or Placebo | Experimental | BMS-955176 10 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days |
|
| Part A-Group 3: BMS-955176 (20 mg) or Placebo | Experimental | BMS-955176 20 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days |
|
| Part A-Group 4: BMS-955176 (40 mg) or Placebo | Experimental | BMS-955176 40 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days |
|
| Part B-Group 5: BMS-955176 + Atazanavir | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-955176 | Drug | BMS-955176 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) and Day 11 after the final dose with BMS-955176 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Time to reach the maximum plasma concentration was directly determined from concentration time data. | Pre-dose Day 1 and Day 10 |
| Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Age 18-55 years inclusive
Men and women: (Parts A and C); men only (Part B)
Women of childbearing potential (WOCBP) must not be pregnant and nursing
BMI: 18.0-35.0 kg/m2
Subjects are infected with HIV-1 (clades B or C) and meet following criteria at the screening:
i) Plasma HIV-1 RNA ≥5,000 copies/mL; ii) Antiretroviral treatment naive (defined as <1 week of ARV treatment) or ART-experienced (protease inhibitor and/or maturation inhibitor naive); iii) Subjects are not eligible for HIV-1 treatment based on the United States Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents or have declined initiation of cART iv) CD4+ lymphocyte measurement ≥200 cells/μL; v) In Parts A and B, all subjects are infected with HIV-1 clade B vi) In Part C, all subjects are infected with HIV-1 clade C
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28369211 | Derived | Hwang C, Schurmann D, Sobotha C, Boffito M, Sevinsky H, Ray N, Ravindran P, Xiao H, Keicher C, Huser A, Krystal M, Dicker IB, Grasela D, Lataillade M. Antiviral Activity, Safety, and Exposure-Response Relationships of GSK3532795, a Second-Generation Human Immunodeficiency Virus Type 1 Maturation Inhibitor, Administered as Monotherapy or in Combination With Atazanavir With or Without Ritonavir in a Phase 2a Randomized, Dose-Ranging, Controlled Trial (AI468002). Clin Infect Dis. 2017 Aug 1;65(3):442-452. doi: 10.1093/cid/cix239. |
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Participants screened were 191 of which 84 were screen failures (Participant withdrew consent: 3, Pregnancy: 3, Participant no longer meets study criteria: 73, Not according to participant's schedule: 1, Not included since cohort was closed: 3 and back up participant: 1). Only 107 participants (Part A: 60; Part B: 28; and Part C: 19) were enrolled.
The study was conducted at 3 centers in 3 countries (1 in Germany, 1 in the United Kingdom, 1 in South Africa) from 04-April-2013 to 29-November-2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A-Group 1: BMS-955176 (5 mg) | Participants infected with Human Immunodeficiency Virus Type-1 (HIV-1) clade B were treated with 5 milligrams (mg) BMS-955176 as oral suspension, once daily (QD) from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG001 | Part A-Group 2: BMS-955176 (10 mg) | Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG002 | Part A-Group 3: BMS-955176 (20 mg) | Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG003 | Part A-Group 4: BMS-955176 (40 mg) | Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG004 | Part A-Group 9: BMS-955176 (80 mg) | Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG005 | Part A-Group 10: BMS-955176 (120 mg) | Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG006 | Placebo Clade B | Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG007 | Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| FG008 | Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| FG009 | Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| FG010 | Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| FG011 | Part C-Group 8: BMS-955176 (40 mg) | Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG012 | Part C-Group 13: BMS-955176 (120 mg) | Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| FG013 | Placebo Clade C | Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Part A (HIV-1 Clade B) |
| |||||||||||||
| Period 2: Part B (HIV-1 Clade B) |
| |||||||||||||
| Period 3: Part C (HIV-1 Clade C Only) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A-Group 1: BMS-955176 (5 mg) | Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG001 | Part A-Group 2: BMS-955176 (10 mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population comprised of all participants who had received at least one dose of study drug. | Posted | Mean | Standard Deviation | Log10 copies per milliliter (c/mL) | Baseline (Day 1) and Day 11 after the final dose with BMS-955176 |
|
Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A-Group 1: BMS-955176 (5 mg) | Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
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| ID | Term |
|---|---|
| C000627567 | BMS-955176 |
| D000069446 | Atazanavir Sulfate |
| D019438 | Ritonavir |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
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BMS-955176 40 mg solution by mouth once daily for 28 days
Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days
|
| Part B-Group 6: BMS-955176 + Atazanavir + Ritonavir | Experimental | BMS-955176 40 mg solution by mouth once daily for 28 days Atazanavir 1 x 300 mg capsules by mouth once daily for 28 days Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days |
|
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Experimental | Atazanavir 1 x 300 mg capsule by mouth once daily for 28 days Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days Tenofovir 1 x 300 mg tablet by mouth once daily for 28 days Emtricitabine 1 x 200 mg capsule once daily for 28 days |
|
| Part C-Group 8: BMS-955176 (40 mg) or Placebo | Experimental | BMS-955176 40 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days |
|
| Part A-Group 9: BMS-955176 (80 mg) or Placebo | Experimental | BMS-955176 80 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days |
|
| Part A-Group 10: BMS-955176 (120 mg) or Placebo | Experimental | BMS-955176 120 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days |
|
| Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or Placebo | Experimental | BMS-955176 ≤120 mg solution by mouth once daily for 14 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 14 days |
|
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Experimental | BMS-955176 80 mg solution by mouth once daily for 28 days Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days |
|
| Part C-Group 13: BMS-955176 (120 mg) or Placebo | Experimental | BMS-955176 120 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days |
|
| Placebo matching with BMS-955176 | Drug | Placebo matching with BMS-955176 |
|
| Atazanavir | Drug | Atazanavir |
|
| Ritonavir | Drug | Ritonavir |
|
| Tenofovir | Drug | Tenofovir |
|
| Emtricitabine | Drug | Emtricitabine |
|
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. |
| Day 1 to end of the study (Day 42) |
| Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) up to Day 24 |
| Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) up to Day 42 |
| Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) up to Day 24 |
| Time to Maximum Decline in Log 10 HIV-1 RNA - Part B | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) up to Day 42 |
| Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) up to Day 24 |
| Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) up to Day 42 |
| Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) up to Day 24 |
| Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | Baseline (Day 1) up to Day 42 |
| Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Tmax was directly determined from concentration time data. | Pre-dose Day 1 and Day 28 |
| Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Pre-dose Day 1 and Day 10 |
| Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. | 24 hours post-dose |
| Maximum Observed Plasma Concentrations (Cmax) - Part B | Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Pre-dose Day 1 and Day 28 |
| Plasma Concentration 24 Hours Post-Dose (C24) - Part B | C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. | 24 hours post-dose |
| Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. | Pre-dose Day 1 and Day 10 |
| Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B | AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. | Pre-dose Day 1 and Day 28 |
| Accumulation Index (AI): Part A and C | Accumulation index was calculated by dividing the AUC(tau) or Cmax or C24 of BMS-955176 on Day 10 by the AUC(TAU) or Cmax or C24, respectively, of BMS-955176 on Day 1. | Baseline and Day 10 |
| Apparent Total Body Clearance: Part A and C | Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). | Baseline (Day 1) to Day 10 |
| Degree of Fluctuation (DF): Part A and C | DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). | Baseline (Day 1) to Day 10 |
| Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). | Baseline (Day 1) to Day 10 |
| Plasma Half-life: Part A and C | Half-life of the terminal log-linear phase, (T-half), was calculated as natural logarithm of 2 (ln2)/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-half was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). | Baseline (Day 1) to Day 10 |
| Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Laboratory abnormalities were determined and graded using the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004. | Day 1 to up to end of the study (Day 42) |
| Number of Participants With Clinically Significant Changes in Heart Rate | Heart rate was measured after the participants had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from Baseline are based on matched postural positions and are calculated as parameter value - Baseline parameter value: Value >100 and change from Baseline > 30, or Value < 55 and change from Baseline < -15. | Day 1 to end of the study (Day 42) |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Participants with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (milliseconds [msec]): Value >200; QRS (msec): Value >120; QT (msec): Value >500 or change from Baseline >30; corrected QT interval Fridericia's formula (QTcF) (msec): Value >450 or change from Baseline >30. | Day 1 to end of the study (Day 42) |
| Number of Participants With Abnormal Changes in Physical Examination | Participants with abnormal changes in physical examination is presented. | Day 1 to end of the study (Day 42) |
| Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Systolic BP (millimeter of mercury [mmHg]): value >140 and change from Baseline >20, or value <90 and change from Baseline <-20; Diastolic BP (mmHg): value >90 and change from Baseline >10, or value <55 and change from Baseline <-10. | Day 1 to end of the study (Day 42) |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG002 | Part A-Group 3: BMS-955176 (20 mg) | Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG003 | Part A-Group 4: BMS-955176 (40 mg) | Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG004 | Part A-Group 9: BMS-955176 (80 mg) | Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG005 | Part A-Group 10: BMS-955176 (120 mg) | Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG006 | Placebo Clade B | Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG007 | Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| BG008 | Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| BG009 | Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| BG010 | Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| BG011 | Part C-Group 8: BMS-955176 (40 mg) | Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG012 | Part C-Group 13: BMS-955176 (120 mg) | Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG013 | Placebo Clade C | Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| BG014 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Part A-Group 2: BMS-955176 (10 mg) | Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| OG002 | Part A-Group 3: BMS-955176 (20 mg) | Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| OG003 | Part A-Group 4: BMS-955176 (40 mg) | Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| OG004 | Part A-Group 9: BMS-955176 (80 mg) | Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. |
| OG005 | Part A-Group 10: BMS-955176 (120 mg) | Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. |
| OG006 | Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| OG007 | Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| OG008 | Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| OG009 | Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. |
| OG010 | Part C-Group 8: BMS-955176 (40 mg) | Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| OG011 | Part C-Group 13: BMS-955176 (120 mg) | Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| OG012 | Placebo Clade B | Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
| OG013 | Placebo Clade C | Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. |
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Time to reach the maximum plasma concentration was directly determined from concentration time data. | Pharmacokinetic Population comprised of all participants who received any study medication and had any available concentration-time data. | Posted | Median | Full Range | Hours | Pre-dose Day 1 and Day 10 |
|
|
|
| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. | All Treated Subjects Population. | Posted | Count of Participants | Participants | Day 1 to end of the study (Day 42) |
|
|
|
| Secondary | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population. | Posted | Median | Full Range | Log10 copies/mL | Baseline (Day 1) up to Day 24 |
|
|
|
| Secondary | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population. | Posted | Median | Full Range | Log10 copies/mL | Baseline (Day 1) up to Day 42 |
|
|
|
| Secondary | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population. | Posted | Median | Full Range | Hours | Baseline (Day 1) up to Day 24 |
|
|
|
| Secondary | Time to Maximum Decline in Log 10 HIV-1 RNA - Part B | Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population. | Posted | Median | Full Range | Hours | Baseline (Day 1) up to Day 42 |
|
|
|
| Secondary | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Cells/microliter | Baseline (Day 1) up to Day 24 |
|
|
|
| Secondary | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Cells/microliter | Baseline (Day 1) up to Day 42 |
|
|
|
| Secondary | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline (Day 1) up to Day 24 |
|
|
|
| Secondary | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. | All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent change | Baseline (Day 1) up to Day 42 |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Tmax was directly determined from concentration time data. | Pharmacokinetic Population. | Posted | Median | Full Range | Hours | Pre-dose Day 1 and Day 28 |
|
|
|
| Secondary | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter | Pre-dose Day 1 and Day 10 |
|
|
|
| Secondary | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter | 24 hours post-dose |
|
|
|
| Secondary | Maximum Observed Plasma Concentrations (Cmax) - Part B | Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter | Pre-dose Day 1 and Day 28 |
|
|
|
| Secondary | Plasma Concentration 24 Hours Post-Dose (C24) - Part B | C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter | 24 hours post-dose |
|
|
|
| Secondary | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/milliliter | Pre-dose Day 1 and Day 10 |
|
|
|
| Secondary | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B | AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/milliliter | Pre-dose Day 1 and Day 28 |
|
|
|
| Secondary | Accumulation Index (AI): Part A and C | Accumulation index was calculated by dividing the AUC(tau) or Cmax or C24 of BMS-955176 on Day 10 by the AUC(TAU) or Cmax or C24, respectively, of BMS-955176 on Day 1. | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Baseline and Day 10 |
|
|
|
| Secondary | Apparent Total Body Clearance: Part A and C | Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliters/minute | Baseline (Day 1) to Day 10 |
|
|
|
| Secondary | Degree of Fluctuation (DF): Part A and C | DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Baseline (Day 1) to Day 10 |
|
|
|
| Secondary | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). | Pharmacokinetic Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter | Baseline (Day 1) to Day 10 |
|
|
|
| Secondary | Plasma Half-life: Part A and C | Half-life of the terminal log-linear phase, (T-half), was calculated as natural logarithm of 2 (ln2)/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-half was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). | Pharmacokinetic Population | Posted | Median | Full Range | Hours | Baseline (Day 1) to Day 10 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Laboratory abnormalities were determined and graded using the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004. | All Treated Subjects Population. | Posted | Count of Participants | Participants | Day 1 to up to end of the study (Day 42) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Heart Rate | Heart rate was measured after the participants had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from Baseline are based on matched postural positions and are calculated as parameter value - Baseline parameter value: Value >100 and change from Baseline > 30, or Value < 55 and change from Baseline < -15. | All Treated Subjects Population. | Posted | Count of Participants | Participants | Day 1 to end of the study (Day 42) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Participants with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (milliseconds [msec]): Value >200; QRS (msec): Value >120; QT (msec): Value >500 or change from Baseline >30; corrected QT interval Fridericia's formula (QTcF) (msec): Value >450 or change from Baseline >30. | All Treated Subjects Population. | Posted | Count of Participants | Participants | Day 1 to end of the study (Day 42) |
|
|
|
| Secondary | Number of Participants With Abnormal Changes in Physical Examination | Participants with abnormal changes in physical examination is presented. | All Treated Subjects Population. | Posted | Count of Participants | Participants | Day 1 to end of the study (Day 42) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Systolic BP (millimeter of mercury [mmHg]): value >140 and change from Baseline >20, or value <90 and change from Baseline <-20; Diastolic BP (mmHg): value >90 and change from Baseline >10, or value <55 and change from Baseline <-10. | All Treated Subjects Population. | Posted | Count of Participants | Participants | Day 1 to end of the study (Day 42) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | Part A-Group 2: BMS-955176 (10 mg) | Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | Part A-Group 3: BMS-955176 (20 mg) | Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG003 | Part A-Group 4: BMS-955176 (40 mg) | Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG004 | Part A-Group 9: BMS-955176 (80 mg) | Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG005 | Part A-Group 10: BMS-955176 (120 mg) | Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG006 | Placebo Clade B | Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 12 | 0 | 12 | 9 | 12 |
| EG007 | Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG008 | Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG009 | Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG010 | Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG011 | Part C-Group 8: BMS-955176 (40 mg) | Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG012 | Part C-Group 13: BMS-955176 (120 mg) | Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG013 | Placebo Clade C | Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. | 0 | 4 | 0 | 4 | 3 | 4 |
| Thrombophlebitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ocular icterus | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| External ear pain | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Gonorrhoea | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Day 10 |
|
| SAEs |
|
| Related SAEs |
|
| Discontinuations due to SAEs |
|
| Discontinuations due to AEs |
|
| AEs |
|
| CD8+ |
|
| CD8+ |
|
| CD8+ |
|
| CD8+ |
|
|
| Day 10 |
|
| Day 10 |
|
|
|
| Day 10 |
|
|
| C24 |
|
| AUC |
|
| Bilirubin (Total) |
|
| QRS > 120 msec |
|
| QT > 500 msec |
|
| QTcB > 450 msec |
|
| QTcF > 450 msec |
|
| Weight |
|
| Body mass index |
|
| DBP |
|