HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Completed · Phase 2

Conditions studied: Infection, Human Immunodeficiency Virus

In brief

The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

Key facts

Study ID

NCT01384734

Run by

ViiV Healthcare

People needed

254

Starts

2011-07-26

Expected to finish

2017-05-12

Last updated by the study team

2018-11-14

Who can join

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

You may qualify if…

• Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening
• Treatment experience with antiretroviral therapies (excluding integrase inhibitors)
• Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1 μM
• Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3

You may not qualify if…

• History (or evidence at Screening) of genotypic resistance to any component of the study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)]
• Certain laboratory and electrocardiogram (ECG) values

Where it is running

• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Coral Gables, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Longview, Texas, United States
• GSK Investigational Site — Ciudad 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 — Rosario, Argentina
• GSK Investigational Site — Bogotá, Colombia
• GSK Investigational Site — Bonn, North Rhine-Westphalia, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Hamburg, Germany
• GSK Investigational Site — München, Germany
• GSK Investigational Site — Guadalajara, Jalisco, Mexico
• GSK Investigational Site — San Francisco, California, United States

Full record on ClinicalTrials.gov

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