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

Stopped early · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT02386098

Run by

ViiV Healthcare

People needed

86

Starts

2015-07-08

Expected to finish

2017-06-07

Last updated by the study team

2018-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Palm Springs, California, United States
• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Tulsa, Oklahoma, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — Rosario, Santa Fe Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Córdoba, Argentina
• GSK Investigational Site — Mar del Plata, Argentina
• GSK Investigational Site — Darlinghurst, New South Wales, Australia
• GSK Investigational Site — Darlinghurst, Sydney, New South Wales, Australia
• GSK Investigational Site — Sydney, New South Wales, Australia
• GSK Investigational Site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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