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A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

This study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.

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 : E/C/F/TAF Placebo
  • drug : E/C/F/TAF
  • drug : E/C/F/TDF
  • drug : E/C/F/TDF Placebo

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Ability to understand and sign a written informed consent form - Plasma HIV 1 RNA levels ? 5,000 copies/mL - No prior use of any approved or experimental anti-HIV drug for any length of time - Screening genotype report must show sensitivity to TDF and emtricitabine (FTC) - Normal ECG - Adequate renal function: Estimated glomerular filtration rate ? 70 mL/min according to the Cockcroft Gault formula - Hepatic transaminases ? 2.5 x upper limit of the normal range (ULN) - Total bilirubin ? 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - CD4+ cell count > 50 cells/µL - Serum amylase ? 5 x ULN - Normal thyroid-stimulating hormone (TSH) - Females of childbearing potential must have a negative serum pregnancy test - Females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drugs - Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing - Female subjects who are postmenopausal must have documentation of cessation of menses for ? 12 months and hormonal failure - Female subjects who have stopped menstruating for ? 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level test at screening - Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 90 days following discontinuation of investigational medicinal product - Age ? 18 years - Life expectancy ? 1 year

External Links

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz
(650) 723-8014
Not Recruiting

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