Infection, Human Immunodeficiency VirusPhase 2NCT01803074
Study to Evaluate a HIV Drug for the Treatment of HIV Infection
A Phase 2 study testing BMS-955176, Atazanavir and Ritonavir in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 1 site in Germany.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Infection, Human Immunodeficiency Virus, HIV Infections
- What is being tested?
- BMS-955176, Atazanavir and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteGermany
- Study dates
- 4 Apr 2013to 29 Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed description
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
- Being tested
- BMS-955176, Placebo matching with BMS-955176, Atazanavir, Ritonavir, Tenofovir
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-955176Drug
BMS-955176
Placebo matching with BMS-955176Drug
Placebo matching with BMS-955176
AtazanavirDrug
Atazanavir
RitonavirDrug
Ritonavir
TenofovirDrug
Tenofovir
EmtricitabineDrug
Emtricitabine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
| Part B-Group 5: BMS-955176 + Atazanavir | Experimental | 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 Receives: Drug: BMS-955176; Drug: Atazanavir |
| 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 Receives: Drug: BMS-955176; Drug: Atazanavir; Drug: Ritonavir |
| 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 Receives: Drug: Atazanavir; Drug: Ritonavir; Drug: Tenofovir; Drug: Emtricitabine |
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
| 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 Receives: Drug: BMS-955176; Drug: Atazanavir |
| 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 Receives: Drug: BMS-955176; Drug: Placebo matching with BMS-955176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and Day 11 after the final dose with BMS-955176
Secondary outcomes (27)
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) up to Day 42
Time to Reach Maximum Plasma Concentration (Tmax) - Part B
Tmax was directly determined from concentration time data.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to end of the study (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study start4 Apr 2013
- Primary completion29 Nov 2014
- Study completion29 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803074
- Sponsor's protocol ID
- 206739
- Other IDs
- 2012-004124-38, AI468-002
- Status last verified
- Nov 2019
- First submitted
- 1 Mar 2013
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28369211
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01803074
- Acronym / sponsor ID
- 206739
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 4 Apr 2013 (actual)
- Primary completion
- 29 Nov 2014 (actual)
- Study completion
- 29 Nov 2014 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Posted 25 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) or Placebo | Experimental | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 | Drug: BMS-955176, Drug: AtazanavirBMS-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 | Drug: BMS-955176, Drug: Atazanavir, Drug: RitonavirBMS-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 | Drug: Atazanavir, Drug: Ritonavir, Drug: Tenofovir, Drug: EmtricitabineAtazanavir 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 | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 | Drug: BMS-955176, Drug: AtazanavirBMS-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 | Drug: BMS-955176, Drug: Placebo matching with BMS-955176BMS-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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-955176BMS-955176 | Drug | Part A-Group 10: BMS-955176 (120 mg) or Placebo, Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or Placebo, Part A-Group 1: BMS-955176 (5 mg) or Placebo, Part A-Group 2: BMS-955176 (10 mg) or Placebo, Part A-Group 3: BMS-955176 (20 mg) or Placebo, Part A-Group 4: BMS-955176 (40 mg) or Placebo, Part A-Group 9: BMS-955176 (80 mg) or Placebo, Part B-Group 12: BMS-955176 (80 mg) + Atazanavir, Part B-Group 5: BMS-955176 + Atazanavir, Part B-Group 6: BMS-955176 + Atazanavir + Ritonavir, Part C-Group 13: BMS-955176 (120 mg) or Placebo, Part C-Group 8: BMS-955176 (40 mg) or Placebo |
| Placebo matching with BMS-955176Placebo matching with BMS-955176 | Drug | Part A-Group 10: BMS-955176 (120 mg) or Placebo, Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or Placebo, Part A-Group 1: BMS-955176 (5 mg) or Placebo, Part A-Group 2: BMS-955176 (10 mg) or Placebo, Part A-Group 3: BMS-955176 (20 mg) or Placebo, Part A-Group 4: BMS-955176 (40 mg) or Placebo, Part A-Group 9: BMS-955176 (80 mg) or Placebo, Part C-Group 13: BMS-955176 (120 mg) or Placebo, Part C-Group 8: BMS-955176 (40 mg) or Placebo |
| AtazanavirAtazanavir | Drug | Part B-Group 12: BMS-955176 (80 mg) + Atazanavir, Part B-Group 5: BMS-955176 + Atazanavir, Part B-Group 6: BMS-955176 + Atazanavir + Ritonavir, Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine |
| RitonavirRitonavir | Drug | Part B-Group 6: BMS-955176 + Atazanavir + Ritonavir, Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine |
| TenofovirTenofovir | Drug | Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine |
| EmtricitabineEmtricitabine | Drug | Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine |
Primary outcome
Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
Time frame: Baseline (Day 1) and Day 11 after the final dose with BMS-955176
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.
27 secondary outcomes
Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
Time frame: 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
Time frame: Day 1 to end of the study (Day 42)
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
Time frame: Baseline (Day 1) up to Day 24
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B
Time frame: Baseline (Day 1) up to Day 42
Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C
Time frame: Baseline (Day 1) up to Day 24
Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
Time frame: Baseline (Day 1) up to Day 42
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
Time frame: Baseline (Day 1) up to Day 24
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B
Time frame: 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
Time frame: Baseline (Day 1) up to Day 24
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
Time frame: Baseline (Day 1) up to Day 42
Time to Reach Maximum Plasma Concentration (Tmax) - Part B
Time frame: Pre-dose Day 1 and Day 28
Maximum Observed Plasma Concentrations (Cmax) - Part A and C
Time frame: Pre-dose Day 1 and Day 10
Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
Time frame: 24 hours post-dose
Maximum Observed Plasma Concentrations (Cmax) - Part B
Time frame: Pre-dose Day 1 and Day 28
Plasma Concentration 24 Hours Post-Dose (C24) - Part B
Time frame: 24 hours post-dose
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
Time frame: Pre-dose Day 1 and Day 10
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B
Time frame: Pre-dose Day 1 and Day 28
Accumulation Index (AI): Part A and C
Time frame: Baseline and Day 10
Apparent Total Body Clearance: Part A and C
Time frame: Baseline (Day 1) to Day 10
Degree of Fluctuation (DF): Part A and C
Time frame: Baseline (Day 1) to Day 10
Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C
Time frame: Baseline (Day 1) to Day 10
Plasma Half-life: Part A and C
Time frame: Baseline (Day 1) to Day 10
Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
Time frame: Day 1 to up to end of the study (Day 42)
Number of Participants With Clinically Significant Changes in Heart Rate
Time frame: Day 1 to end of the study (Day 42)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Time frame: Day 1 to end of the study (Day 42)
Number of Participants With Abnormal Changes in Physical Examination
Time frame: 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)
Time frame: Day 1 to end of the study (Day 42)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28369211Hwang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-955176, Atazanavir and Ritonavir in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 (time frame: Baseline (Day 1) and Day 11 after the final dose with BMS-955176). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.