Study to Evaluate a HIV Drug for the Treatment of HIV Infection
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ClinicalTrials.gov Identifier: NCT01803074 |
Recruitment Status
:
Completed
First Posted
: March 4, 2013
Last Update Posted
: January 20, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infection, Human Immunodeficiency Virus | Drug: BMS-955176 Drug: Placebo matching with BMS-955176 Drug: Atazanavir Drug: Ritonavir Drug: Tenofovir Drug: Emtricitabine | Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 With Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Part A-Group 1: BMS-955176 (5 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
Experimental: Part A-Group 2: BMS-955176 (10 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
Experimental: Part A-Group 3: BMS-955176 (20 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
Experimental: Part A-Group 4: BMS-955176 (40 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
Experimental: Part B-Group 5: BMS-955176 + Atazanavir
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 |
Drug: BMS-955176
BMS-955176
Drug: Atazanavir
Atazanavir
|
Experimental: Part B-Group 6: BMS-955176 + Atazanavir + Ritonavir
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 |
Drug: BMS-955176
BMS-955176
Drug: Atazanavir
Atazanavir
Drug: Ritonavir
Ritonavir
|
Experimental: Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
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 |
Drug: Atazanavir
Atazanavir
Drug: Ritonavir
Ritonavir
Drug: Tenofovir
Tenofovir
Drug: Emtricitabine
Emtricitabine
|
Experimental: Part C-Group 8: BMS-955176 (40 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
Experimental: Part A-Group 9: BMS-955176 (80 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
Experimental: Part A-Group 10: BMS-955176 (120 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
Experimental: Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
Experimental: Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
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 |
Drug: BMS-955176
BMS-955176
Drug: Atazanavir
Atazanavir
|
Experimental: Part C-Group 13: BMS-955176 (120 mg) or Placebo
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 |
Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
|
- Change in plasma HIV-1 RNA levels from baseline (Day 1-predose) on Day 11 with monotherapy [ Time Frame: Baseline (Day 1-predose) and Day 11 after the final dose with BMS-955176 ]
- Safety based on frequency of Adverse events (AEs), serious AEs, discontinuations due to AEs, findings of marked abnormalities in vital signs, clinical laboratory tests, ECG readings and physical examinations [ Time Frame: Up to day 24 (Groups 1-4, 8-10 and 13), up to day 28 (optional group 11) and up to day 42 (Part B) ]
- Time course of the change from baseline in plasma log10 HIV-1 RNA levels and the time of maximum decrease during the 10-day monotherapy and combination therapy of BMS-955176 with Atazanavir (ATV) +/- Ritonavir (RTV) [ Time Frame: Day 1-24 (Groups 1-4, 8-10 & 13), Day 1-28 (optional group 11) and Day 1-42 (Part B) ]
- Change from baseline in CD4+ and CD8+ lymphocyte counts and percentages following monotherapy and combination therapy of BMS-955176 with ATV +/- RTV in HIV-1 infected subjects [ Time Frame: Day 1-24 (Groups 1-4, 8-10 & 13), Day 1-28 (optional group 11) and Day 1-42 (Part B) ]
- Maximum observed plasma concentration (Cmax) of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]
- Observed concentration at 24 hours postdose (C24) of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]
- Time of maximum observed plasma concentration (Tmax) of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]
- Trough observed plasma concentration (Ctrough) of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]
- Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]
- Accumulation Index (AI), calculated as ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]
- Apparent total body clearance (CLT/F) of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]
- Terminal Plasma half-life (T-Half)-after last dose only of BMS-955176 [ Time Frame: Day 10 (Part A and C), Day 14 (optional group 11) and Day 28 (Part B) ]
- Degree of Fluctuation (DF), calculated as steady state (Cmax-C24) / (AUC(TAU) / 24) of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]
- Average steady-state plasma concentration (Css-av), calculated as AUC(TAU) / TAU of BMS-955176 [ Time Frame: 26 timepoints up to Day 10 (Groups 1-4, 8-10 & 13), 30 timepoints up to Day 14 (optional group 11) and 24 timepoints up to Day 28 (Part B) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- History of genotypic and/or phenotypic drug resistance testing showing resistance to protease inhibitors
- Any significant acute or chronic medical illness which is not stable or is not controlled with medication or not consistent with HIV-1 infection
- Receive antiretroviral treatment within 12 weeks prior to screening
- Currently co-infected with hepatitis C or hepatitis B
- Previously received an HIV maturation inhibitor or HIV protease inhibitor
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Acute diarrhea lasting ≥1 day, within 3 weeks prior to randomization
- Subjects with history of Gilbert's syndrome
- Subjects previously received an HIV maturation inhibitor or HIV protease inhibitor
- A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes. A personal or family history of long QT syndrome
- Patients who are unwilling to practice adequate infection protection during and after study participation to minimize potential for spread of HIV infection, including HIV which may have developed resistance to HIV maturation inhibitor and/or ATV
- Any gastrointestinal surgery that could impact upon the absorption of study drug
- Smoking >10 cigarettes per day
- PR ≥210 msec; QRS ≥120 msec; QT ≥500 msec; and QTcF ≥470 msec for women and ≥450 msec for men
- Evidence of second or third degree heart block prior to study drug
- Absolute Neutrophil Count <(ANC) 0.7 x lower limit of normal (LLN)
- Hemoglobin <0.8 x LLN
- Alanine aminotransferase (ALT) >1.25 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >1.25 x ULN
- Total Bilirubin >1.25 x ULN
- Creatinine clearance <60 mL/mim
- Positive urine screen for drugs of abuse without a valid prescription (subjects positive for cannabinoids and/or amphetamines will be included)
- Positive blood screen for hepatitis C virus (HCV) RNA, hepatitis B surface antigen (consistent with active or chronic hepatitis B), or HIV-2 antibody
- History of any significant drug allergy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803074
Germany | |
GSK Investigational Site | |
Berlin, Germany, 13353 |
Study Director: | GSK Clinical Trials | ViiV Healthcare |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ViiV Healthcare |
ClinicalTrials.gov Identifier: | NCT01803074 History of Changes |
Other Study ID Numbers: |
206739 2012-004124-38 ( EudraCT Number ) AI468-002 ( Other Identifier: Bristol-Myers Squibb ) |
First Posted: | March 4, 2013 Key Record Dates |
Last Update Posted: | January 20, 2017 |
Last Verified: | January 2017 |
Additional relevant MeSH terms:
Infection Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Ritonavir Atazanavir Sulfate |
Tenofovir Emtricitabine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |