Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults
| Status: | Terminated |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/21/2018 |
| Start Date: | May 12, 2015 |
| End Date: | August 21, 2017 |
A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults
The purpose of this study is to find at least one dose of BMS-955176 that will be safe,
effective and tolerable for HIV-1 infected treatment naive adults.
effective and tolerable for HIV-1 infected treatment naive adults.
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
Inclusion Criteria:
- Men and non-pregnant women, at least 18 years of age
- Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week
of an antiretroviral drug
- Plasma HIV-1 RNA ≥ 1000 copies/mL
- CD4 T-cell count > 200 cells/mm3
Exclusion Criteria:
- Resistance or partial resistance to any study drug determined by tests at Screening
- Current or historical genotypic and/or phenotypic drug resistance testing showing
certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors
- 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
9
sites
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