HIV InfectionsPhase 2NCT02386098
Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults
A Phase 2 study testing BMS-955176, Atazanavir (ATV) and Ritonavir (RTV) in people with HIV Infections, run by ViiV Healthcare at 64 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- BMS-955176, Atazanavir (ATV) and Ritonavir (RTV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 64 sitesin 13 countries
- Study dates
- 8 Jul 2015to 7 Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and non-pregnant women, at least 18 years of age
- Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or without documented resistance)
- CD4+ T-cell count > 50 cells/mm3
- Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC < 2.2; DTG; TDF)
Who cannot join
- Antiretroviral treatment-experienced adults who have failed > 2 ARV regimens
- Resistance or partial resistance to any study drug determined by tests at Screening
- Historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs
- Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)
- Blood tests that indicate normal liver function
- Hemoglobin < 8.0 g/dL, Platelets < 50,000 cells/mm3
Trial locations and contacts
64 sites in 13 countries.
64 sites in 13 countries
United States16 sites
GSK Investigational Site
Atlanta, Georgia, 30312
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Beverly Hills, California, 90211
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
New Haven, Connecticut, 06520
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Palm Springs, California, 92262
GSK Investigational Site
Tampa, Florida, 33614
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
Tulsa, Oklahoma, 74135
GSK Investigational Site
West Palm Beach, Florida, 33401
Canada8 sites
GSK Investigational Site
Montreal, Quebec, H2L 4P9
GSK Investigational Site
Montreal, Quebec, H2L 5B1
GSK Investigational Site
Montreal, Quebec, H4A 3J1
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Toronto, Ontario, M5G 2N2
GSK Investigational Site
Vancouver, British Columbia, V6Z 1Y6
GSK Investigational Site
Vancouver, British Columbia, V6Z 2C7
GSK Investigational Site
Winnipeg, Manitoba, R3A 1R9
Mexico7 sites
GSK Investigational Site
DF, 14000
GSK Investigational Site
Distrito Federal, 03720
GSK Investigational Site
Guadalajara, Jalisco, 44280
GSK Investigational Site
Juárez, Chihuahua, 32330
GSK Investigational Site
Mexico City, 06700
GSK Investigational Site
Mexico City, CP 14080
GSK Investigational Site
Oaxaca City, 68000
Argentina6 sites
GSK Investigational Site
Buenos Aires, 1141
GSK Investigational Site
Buenos Aires, 1202
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1405CKC
GSK Investigational Site
Córdoba, X5000JJS
GSK Investigational Site
Mar del Plata, B7600FZN
GSK Investigational Site
Rosario, Santa Fe Province, 2000
Russia5 sites
GSK Investigational Site
Irkutsk, 664035
GSK Investigational Site
Krasnodar, 350015
GSK Investigational Site
Moscow, 105275
GSK Investigational Site
Saint Petersburg, 190103
GSK Investigational Site
Yekaterinburg, 620102
Colombia4 sites
GSK Investigational Site
Barranquilla
GSK Investigational Site
Bogotá, 111311
GSK Investigational Site
Bogotá
GSK Investigational Site
Cali
Peru4 sites
GSK Investigational Site
Lima, 1
GSK Investigational Site
Lima, Lima 11
GSK Investigational Site
Lima, Lima 14
GSK Investigational Site
Lima, Lima 31
South Africa4 sites
GSK Investigational Site
Bloemfontein, Free State, 9301
GSK Investigational Site
Port Elizabeth, Eastern Cape, 6001
GSK Investigational Site
Tembisa, 1632
GSK Investigational Site
Westdene, 2092
Australia3 sites
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Darlinghurst, Sydney, New South Wales, 2010
GSK Investigational Site
Sydney, New South Wales, 2010
Chile3 sites
GSK Investigational Site
Providencia, Santiago de Chile, 7500922
GSK Investigational Site
Santiago, Región Metro de Santiago, 8330074
GSK Investigational Site
Santiago, 8360159
Taiwan2 sites
GSK Investigational Site
Kaohsiung City, 81346
GSK Investigational Site
Taipei, 100
About this study
Official title: A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults
The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.
- Conditions
- HIV Infections
- Being tested
- BMS-955176, Atazanavir (ATV), Ritonavir (RTV), Dolutegravir (DTG), Tenofovir (TDF)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-955176Drug
HIV Maturation Inhibitor
Atazanavir (ATV)Drug
Atazanavir
Ritonavir (RTV)Drug
Ritonavir
Dolutegravir (DTG)Drug
Dolutegravir
Tenofovir (TDF)Drug
Tenofovir
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-955176 + ATV + RTV + DTG | Experimental | BMS-955176 at 120 mg tablet per day + Atazanavir boosted with ritonavir (ATV/r) 300/100 mg tablets per day + DTG 50 mg tablet per day, orally Receives: Drug: BMS-955176; Drug: Atazanavir (ATV); Drug: Ritonavir (RTV); Drug: Dolutegravir (DTG) |
| Arm 2: TDF + ATV + RTV + DTG | Other | TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally Receives: Drug: Atazanavir (ATV); Drug: Ritonavir (RTV); Drug: Dolutegravir (DTG); Drug: Tenofovir (TDF) |
| Arm 3: BMS-955176 + ATV + DTG | Experimental | BMS-955176 at 120 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally Receives: Drug: BMS-955176; Drug: Atazanavir (ATV); Drug: Dolutegravir (DTG) |
| Arm 4: BMS-955176 + ATV + DTG | Experimental | BMS-955176 at 180 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally Receives: Drug: BMS-955176; Drug: Atazanavir (ATV); Drug: Dolutegravir (DTG) |
| Arm 5: TDF + ATV + RTV + DTG | Other | TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally Receives: Drug: Atazanavir (ATV); Drug: Ritonavir (RTV); Drug: Dolutegravir (DTG); Drug: Tenofovir (TDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which used the last on-treatment plasma HIV-1 RNA measurement, within an FDA-specified visit window (18 to 30 weeks), to determine response. Analysis was performed on the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF.
Measured: Week 24
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2
Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.
Measured: Week 24
Secondary outcomes (26)
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <40 c/mL at Weeks 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis.
Measured: Weeks 48 and 96
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2
Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.
Measured: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis.
Measured: Weeks 24, 48 and 96
Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2
Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the Study during Stage 1.
Measured: Weeks 24, 48 and 96
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1
Blood samples were collected for analysis of HIV-1 RNA. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
Measured: Baseline and up to Week 72
Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2
This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Measured: Baseline and up to Week 96
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1
The CD4+ cell count was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
Measured: Baseline and up to Week 72
Change From Baseline in CD4+ Cell Count Over Time-Stage 2
This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Measured: Baseline and up to Week 96
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1
The percentage of CD4+ cells was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
Measured: Baseline and up to Week 72
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2
This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Measured: Baseline and up to Week 96
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1
An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or medical events that may jeopardize the participant or require intervention (medical or surgical) to prevent one of the outcomes mentioned before. The number of participants with SAEs and AELDs are presented.
Measured: Up to Week 96
Number of Participants With SAEs and AELDs-Stage 2
This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Measured: Up to Week 96
Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1
The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented.
Measured: Up to Week 96
Number of Participants With Occurrence of New AIDS Defining Events-Stage 2
This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Measured: Up to Week 96
Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1
The pharmacokinetic (PK) assessments were planned to be performed on PK Population, which comprised of all treated participants who had any available concentration-time data; however, it was not performed due to the early termination of the study in Stage 1.
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Cmax for BMS-955176-Stage 2
This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Time of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1
PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Tmax for BMS-955176-Stage 2
This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1
PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Ctau for BMS-955176-Stage 2
This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1
PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
C0 for BMS-955176-Stage 2
This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1
PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
AUC(Tau) for BMS-955176-Stage 2
This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Measured: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Number of Participants With Emergence of HIV Drug Resistance-Stage 1
Emergence of drug resistance was planned to be assessed using the most current version of International AIDS Society-United States of America (IAS-USA); however, it was not assessed due to the early termination of the study in Stage 1.
Measured: Up to Week 96
Number of Participants With Emergence of HIV Drug Resistance-Stage 2
This end point was not evaluated, as the resulting information would only have been needed to help assess the risk for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Measured: Up to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study start8 Jul 2015
- Primary completion7 Jun 2017
- Study completion7 Jun 2017
Why it stopped: GI Intolerability
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.
- Other trials for HIV InfectionsStudies 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
- None (open label)
- Enrolment
- 86 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
- NCT02386098
- Sponsor's protocol ID
- 205892
- Other IDs
- AI468-048
- Status last verified
- Aug 2018
- First submitted
- 6 Mar 2015
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults
- ClinicalTrials.gov ID
- NCT02386098
- Acronym / sponsor ID
- 205892
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: GI Intolerability
- Enrolment
- 86 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 8 Jul 2015 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Posted 20 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-955176 + ATV + RTV + DTG | Experimental | Drug: BMS-955176, Drug: Atazanavir (ATV), Drug: Ritonavir (RTV), Drug: Dolutegravir (DTG)BMS-955176 at 120 mg tablet per day + Atazanavir boosted with ritonavir (ATV/r) 300/100 mg tablets per day + DTG 50 mg tablet per day, orally |
| Arm 2: TDF + ATV + RTV + DTG | Other | Drug: Atazanavir (ATV), Drug: Ritonavir (RTV), Drug: Dolutegravir (DTG), Drug: Tenofovir (TDF)TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally |
| Arm 3: BMS-955176 + ATV + DTG | Experimental | Drug: BMS-955176, Drug: Atazanavir (ATV), Drug: Dolutegravir (DTG)BMS-955176 at 120 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally |
| Arm 4: BMS-955176 + ATV + DTG | Experimental | Drug: BMS-955176, Drug: Atazanavir (ATV), Drug: Dolutegravir (DTG)BMS-955176 at 180 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally |
| Arm 5: TDF + ATV + RTV + DTG | Other | Drug: Atazanavir (ATV), Drug: Ritonavir (RTV), Drug: Dolutegravir (DTG), Drug: Tenofovir (TDF)TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and non-pregnant women, at least 18 years of age
- Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or without documented resistance)
- CD4+ T-cell count > 50 cells/mm3
- Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC < 2.2; DTG; TDF)
Key exclusion criteria (6 listed)
- Antiretroviral treatment-experienced adults who have failed > 2 ARV regimens
- Resistance or partial resistance to any study drug determined by tests at Screening
- Historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs
- Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)
- Blood tests that indicate normal liver function
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-955176HIV Maturation Inhibitor | Drug | Arm 1: BMS-955176 + ATV + RTV + DTG, Arm 3: BMS-955176 + ATV + DTG, Arm 4: BMS-955176 + ATV + DTG |
| Atazanavir (ATV)Atazanavir | Drug | Arm 1: BMS-955176 + ATV + RTV + DTG, Arm 2: TDF + ATV + RTV + DTG, Arm 3: BMS-955176 + ATV + DTG, Arm 4: BMS-955176 + ATV + DTG, Arm 5: TDF + ATV + RTV + DTG |
| Ritonavir (RTV)Ritonavir | Drug | Arm 1: BMS-955176 + ATV + RTV + DTG, Arm 2: TDF + ATV + RTV + DTG, Arm 5: TDF + ATV + RTV + DTG |
| Dolutegravir (DTG)Dolutegravir | Drug | Arm 1: BMS-955176 + ATV + RTV + DTG, Arm 2: TDF + ATV + RTV + DTG, Arm 3: BMS-955176 + ATV + DTG, Arm 4: BMS-955176 + ATV + DTG, Arm 5: TDF + ATV + RTV + DTG |
| Tenofovir (TDF)Tenofovir | Drug | Arm 2: TDF + ATV + RTV + DTG, Arm 5: TDF + ATV + RTV + DTG |
Primary outcome
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1
Time frame: Week 24
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which used the last on-treatment plasma HIV-1 RNA measurement, within an FDA-specified visit window (18 to 30 weeks), to determine response. Analysis was performed on the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF.
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2
Time frame: Week 24
Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.
26 secondary outcomes
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1
Time frame: Weeks 48 and 96
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2
Time frame: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1
Time frame: Weeks 24, 48 and 96
Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2
Time frame: Weeks 24, 48 and 96
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1
Time frame: Baseline and up to Week 72
Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2
Time frame: Baseline and up to Week 96
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1
Time frame: Baseline and up to Week 72
Change From Baseline in CD4+ Cell Count Over Time-Stage 2
Time frame: Baseline and up to Week 96
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1
Time frame: Baseline and up to Week 72
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2
Time frame: Baseline and up to Week 96
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1
Time frame: Up to Week 96
Number of Participants With SAEs and AELDs-Stage 2
Time frame: Up to Week 96
Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1
Time frame: Up to Week 96
Number of Participants With Occurrence of New AIDS Defining Events-Stage 2
Time frame: Up to Week 96
Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Cmax for BMS-955176-Stage 2
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Time of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Tmax for BMS-955176-Stage 2
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Ctau for BMS-955176-Stage 2
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
C0 for BMS-955176-Stage 2
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
AUC(Tau) for BMS-955176-Stage 2
Time frame: Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Number of Participants With Emergence of HIV Drug Resistance-Stage 1
Time frame: Up to Week 96
Number of Participants With Emergence of HIV Drug Resistance-Stage 2
Time frame: Up to Week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
64 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-955176, Atazanavir (ATV) and Ritonavir (RTV) in people with HIV Infections, run by ViiV Healthcare at 64 sites in 13 countries.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Canada, Mexico, Argentina, Russia and 8 more countries. 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 20 Aug 2018). 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?
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2018.