A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

To evaluate the safety and efficacy of Stribild, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.

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 : Stribild
  • drug : Stribild
  • drug : Atripla
  • drug : Atripla

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Plasma HIV-1 RNA levels ? 5,000 copies/mL - No prior use of any approved or investigational antiretroviral drug for any length of time - Screening genotype report must show sensitivity to FTC, TDF, and EFV - Normal electrocardiogram (ECG) - Adequate renal function (estimated glomerular filtration rate ? 70 mL/min according to the Cockcroft Gault formula) - Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ? 5 x the upper limit of the normal range (ULN) - Total bilirubin ? 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase ? 5 x ULN - Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug - Age ? 18 years - Life expectancy ? 1 year

External Links

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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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