Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

Stopped early · Phase 2

Conditions studied: Infection, Human Immunodeficiency Virus

In brief

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.

Key facts

Study ID

NCT02415595

Run by

ViiV Healthcare

People needed

210

Starts

2015-05-12

Expected to finish

2017-08-21

Last updated by the study team

2018-09-19

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-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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Santa Fe, New Mexico, United States
• GSK Investigational Site — Tulsa, Oklahoma, United States
• GSK Investigational Site — Fort Worth, Texas, United States
• GSK Investigational Site — Ciudad Autonoma 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 — Edmonton, Alberta, Canada
• GSK Investigational Site — Winnipeg, Manitoba, Canada
• GSK Investigational Site — Ottawa, Ontario, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Québec, Quebec, Canada
• GSK Investigational Site — Santiago, Región Metro de Santiago, Chile
• GSK Investigational Site — Santiago, Chile
• GSK Investigational Site — Santiago, Chile
• GSK Investigational Site — Le Kremlin-Bicêtre, France
• GSK Investigational Site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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