Available Clinical Trials: Prior HIV Treatment-Detectable Viral Load

Return to Clinical Trials Index

GSK SAILING ING111762

Study ID: GSK SAILING ING111762

Sponsor: Gilead Sciences

Title: NOW OPEN: A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-NaÔve, Antiretroviral Therapy-Experienced Adults

Summary: ING111762 is a 48 week, randomized, double-blind, active-controlled study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naÔve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent.

Phase #: 3

Study Design: Randomized, Double-Blind Study

Eligibility Criteria:

Inclusion Criteria:

• Antiretroviral therapy (ART)-experienced
• HIV-1 infection as documented by HIV-1 RNA >400 copies/mL
• Have documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents.
• Integrase inhibitor (INI)-naÔve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572).

Exclusion Criteria:

• Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen.
• Any evidence of an active AIDS-defining condition (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ less than 200c/mm3).
• Anticipated need for hepatitis C therapy during the study.
• History of malignancy within the past 5 years or ongoing malignancy.

Drugs/Treatment Provided:

Arm A: Experimental - GSK1349572 + Raltegravir Placebo Assigned Interventions: Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily + optimized background regimen

Arm B: Active Comparator - Raltegravir + GSK1349572 Placebo Assigned Interventions: Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily + optimized background regimen

Duration: 48 Weeks

Compensation to Participant: $50 per study visit

Principal Investigator: Donna Mildvan, MD

Study Location:
Beth Israel Medical Center
AIDS Clinical Trials Unit
350 East 17th Street, 3rd Floor
New York, NY 10003

Contact Information:
Ph: 212-420-4519 or 800-483-7339

Email: Trials@BethIsraelNY-HIVtrials.org

ALL TRIALS IN THIS CATEGORY

Click highlighted ID code below to view individual trial details.

Pfizer A4001067

An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-Experienced HIV-1 Infected Patients (POEM)

GSK SAILING ING111762

NOW OPEN. A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-NaÔve, Antiretroviral Therapy-Experienced Adults

Call toll-free: 800.483.7339