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

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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.


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
Dallas, Texas 75230
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Atlanta, Georgia 30341
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Atlanta, GA
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Austin, Texas 78705
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Austin, TX
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Beverly Hills, California 90211
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Beverly Hills, CA
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Bronx, New York 10461
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Bronx, NY
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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Ciudad Autonoma de Buenos Aires,
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DeLand, Florida 32720
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DeLand, FL
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Fort Lauderdale, Florida 33308
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Fort Lauderdale, FL
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Los Angeles, California 90025
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Los Angeles, CA
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New Haven, Connecticut 06520
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New Haven, CT
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New York, New York 10032
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New York, NY
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Orlando, Florida 32806
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Orlando, FL
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Palm Springs, California 92262
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Palm Springs, CA
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Tampa, Florida 33612
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Tampa, FL
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Tulsa, Oklahoma 74105
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Tulsa, OK
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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