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

Not Recruiting

Trial ID: NCT01095796


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.

Official Title

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

Stanford Investigator(s)

Philip Grant
Philip Grant

Asst Prof-Univ Med Line, 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

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

   - 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

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, EFV, or TDF; or subjects with
   any known allergies to the excipients of Stribild or Atripla 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: Atripla

drug: Stribild Placebo

drug: Atripla Placebo

drug: Atripla

drug: Stribild

Not Recruiting

Contact Information

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