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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT01106586
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
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
time
- 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
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Debbie Slamowitz
650-723-2804