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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-Nave and -Experienced Adults With No Darunavir Resistance-associated Mutations

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-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an extension period to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : COBI
  • drug : NRTIs
  • drug : DRV

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Adult ? 18 years males or non-pregnant females - Ability to understand and sign a written informed consent form - General medical condition that does not interfere with the assessments and the completion of the trial - Treatment Naive: 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 ? 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 - Normal electrocardiogram (ECG) - Hepatic transaminases ? 2.5 upper limit of normal (ULN) - Total bilirubin ? 1.5 mg/dL - Adequate hematologic function - Serum amylase ? 2 ULN and serum lipase ? 3 ULN - Adequate renal function: Estimated glomerular filtration rate ? 80 mL/min - Females of childbearing potential must agree to utilize protocol-recommended methods of contraception, or be nonheterosexually active, practice sexual abstinence or have a vasectomized partner from Screening throughout the duration of the study period and for 30 days following the last dose of study drug. - Male subjects must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse from the Screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or be nonheterosexually active, practice sexual abstinence, or be vasectomized.

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Contact information

Primary Contact:

Debbie Slamowitz 650-723-2804

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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