Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02386098
• Date of registration: 06/03/2015
• Prospective Registration: Yes
• Primary sponsor: ViiV Healthcare
• Public title: Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults
• Scientific 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
• Date of first enrolment: July 8, 2015
• Target sample size: 86
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02386098
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, Colombia, Mexico, Peru, Puerto Rico, Russian Federation, South Africa, Taiwan, Thailand, Turkey, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: ViiV Healthcare

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Atazanavir (ATV)

Drug: Tenofovir (TDF)

Drug: BMS-955176

Drug: Ritonavir (RTV)

Drug: Dolutegravir (DTG)

Primary Outcome(s)

Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2 [Time Frame: Week 24]

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]

Secondary Outcome(s)

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])]

Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 [Time Frame: Baseline and up to Week 72]

Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1 [Time Frame: Up to Week 96]

Change From Baseline in CD4+ Cell Count 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]

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])]

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])]

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])]

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])]

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])]

Number of Participants With Occurrence of New AIDS Defining Events-Stage 2 [Time Frame: Up to Week 96]

Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1 [Time Frame: Weeks 48 and 96]

Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2 [Time Frame: Baseline and up to Week 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 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]

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])]

Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2 [Time Frame: Weeks 48 and 96]

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])]

Number of Participants With Emergence of HIV Drug Resistance-Stage 2 [Time Frame: Up to Week 96]

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])]

Number of Participants With Emergence of HIV Drug Resistance-Stage 1 [Time Frame: Up to Week 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]

Number of Participants With SAEs and AELDs-Stage 2 [Time Frame: Up to Week 96]

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])]

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]

Secondary ID(s)

AI468-048

205892

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Results

• Results available: Yes
• Date Posted: 20/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02386098