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

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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.


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
Los Angeles, California 90025
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Los Angeles, CA
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Atlanta, Georgia 30341
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Atlanta, GA
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Beverly Hills, California 90211
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Beverly Hills, CA
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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Ciudad Autonoma de Buenos Aires,
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Decatur, Georgia 30033
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Decatur, GA
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DeLand, Florida 32720
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DeLand, FL
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Fort Worth, Texas 76104
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Fort Worth, TX
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Santa Fe, New Mexico 87505
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Santa Fe, NM
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Tulsa, Oklahoma 74105
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Tulsa, OK
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