Available Clinical Trials: Prior HIV Treatment-Undetectable Viral Load

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Gilead US-264-0106

Study ID: Gilead US-264-0106

Sponsor: Gilead Sciences

Title: A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV 1 Infected Patients

Summary: Randomized, open-label, multicenter, active-controlled study to evaluate switching from regimens consisting of a ritonavir-boosted PI and two NRTIs to a fixed dose regimen consisting of FTC/RPV/TDF in virologically suppressed, HIV 1 infected subjects.

Phase #: 3

Study Design: Randomized, Open-Label Study

Eligibility Criteria:

Inclusion Criteria:

• Currently receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIs continuously for greater than or equal to 6 months preceding the screening visit
• Have plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for greater than or equal to 6 months prior to the screening visit and have HIV RNA less than 50 copies/mL at the screening visit
• Be on their first or second antiretroviral drug regimen; if on their second regimen, must not have had HIV 1 RNA >50 copies/mL at the time of the change in antiretroviral drugs, nor ever experienced two consecutive HIV RNA >50 copies/mL after first achieving HIV RNA 50 copies/mL
• Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents
  

Exclusion Criteria:

• A new AIDS defining condition diagnosed within the 30 days prior to screening except CD4 cell count and/or percentage criteria
• Current alcohol or substance abuse
• A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.

Drugs/Treatment Provided:

Arm A: Experimental: Immediate switch to FTC/RPV/TDF fixed dose regimen Fixed dose regimen of emtricitabine 200 mg/rilpivirine 25 mg/tenofovir DF 300 mg QD

Arm B: Experimental: Delayed switch to FTC/RPV/TDF fixed dose regimen Fixed dose regimen of emtricitabine 200 mg/rilpivirine 25 mg/tenofovir DF 300 mg QD

Duration: 96 weeks

Compensation to Participant: $20 per on study clinic 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

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Gilead US-264-0106

NO LONGER RECRUITING. A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV 1 Infected Patients

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