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GS-US-216-0130

Study ID: GS-US-216-0130

Sponsors: Gilead Sciences

Title: NO LONGER RECRUITING. A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV 1 Infected, Antiretroviral Treatment-NaÔve and -Experienced Adults With No Darunavir Resistance-associated Mutations

Summary: The purpose of this study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naÔve and -experienced adult subjects with no Darunavir (DRV) resistance-associated mutations.

Phase #: 3B

Study Design: Non-Randomized Open Label Treatment

Eligibility Criteria:

Inclusion Criteria:

• Treatment NaÔve: No prior use of any approved or investigational antiretroviral drug for any length of time OR
• Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening
• Plasma HIV 1 RNA levels greater than or equal to 1000 copies/mL at screening
• Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase inhibitors (NRTIs) and no darunavir resistance associated mutations
  

Exclusion Criteria:

• Previous or current use of darunavir
• A new AIDS-defining condition diagnosed within the 30 days prior to screening
• Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
• A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma
• Participation in any other clinical trial

Drugs/Treatment Provided:

Duration: 48 weeks

Compensation to Participant: $20.00/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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GS-US-216-0130

NO LONGER RECRUITING. A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV 1 Infected, Antiretroviral Treatment-NaÔve and -Experienced Adults With No Darunavir Resistance-associated Mutations

Call toll-free: 800.483.7339