Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Not Recruiting

Trial ID: NCT01106586


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 ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

Official Title

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

Stanford Investigator(s)

Philip Grant
Philip Grant

Assistant Professor of Medicine (Infectious Diseases)


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 at screening

   - No prior use of any approved or investigational antiretroviral drug for any length of

   - Screening genotype report must show sensitivity to FTC, TDF, and ATV

   - 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 30 days following the last dose of study drug

   - Age ≥ 18 years

   - Life expectancy ≥ 1 year

Exclusion Criteria:

   - A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within
   the 30 days prior to screening

   - Receiving drug treatment for hepatitis C, or anticipated to receive treatment for
   hepatitis C

   - Subjects experiencing decompensated cirrhosis

   - Females who are breastfeeding

   - Positive serum pregnancy test (female of childbearing potential)

   - Implanted defibrillator or pacemaker

   - Current alcohol or substance use judged by the Investigator to potentially interfere
   with subject study compliance

   - History of malignancy within the past 5 years or ongoing malignancy other than
   cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous
   squamous carcinoma

   - Active, serious infections (other than HIV-1 infection) requiring parenteral
   antibiotic or antifungal therapy within 30 days prior to baseline

   - Medications contraindicated for use with EVG, COBI, FTC, TDF, ATV, or ritonavir or
   subjects with any known allergies to the excipients of Stribild tablets, Truvada
   tablets, ATV capsules or ritonavir tablets

   - Participation in any other clinical trial without prior approval

   - Any other clinical condition or prior therapy that, in the opinion of the
   Investigator, would make the subject unsuitable for the study or unable to comply with
   the dosing requirements


drug: Stribild

drug: ATV

drug: Ritonavir

drug: FTC/TDF

drug: Stribild Placebo

drug: ATV Placebo

drug: RTV Placebo

drug: FTC/TDF Placebo

drug: Stribild

Not Recruiting

Contact Information

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