Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults
| Status: | Terminated |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/22/2018 |
| Start Date: | July 8, 2015 |
| End Date: | June 7, 2017 |
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.
atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious,
safe, and well-tolerated in HIV-1 infected treatment experienced adults.
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
We found this trial at
17
sites
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