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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT01797445
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
Assistant Professor of Medicine (Infectious Diseases)
Key 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 ≥ 1,000 copies/mL at screening
- No prior use of any approved or investigational antiretroviral drug for any length of
time, except the use for pre-exposure prophylaxis (PREP), or post-exposure prophylaxis
(PEP) up to 6 months prior to screening
- Screening genotype report must show sensitivity to elvitegravir, emtricitabine,
tenofovir DF
- Normal electrocardiogram (ECG)
- Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the
Cockcroft-Gault formula for creatinine clearance
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 × ULN
- Males and females of childbearing potential must agree to utilize highly effective
contraception methods or be non-heterosexually active or practice sexual abstinence
from screening throughout the duration of study treatment and for 30 days following
the last dose of study drug
- Females 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
- Females 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 at
screening within the post-menopausal range based on the Central Laboratory reference
range
- Age ≥ 18 years
Key Exclusion Criteria:
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody positive
- Individuals experiencing decompensated cirrhosis
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere
with 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
- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the individual unsuitable for the study or unable to comply
with dosing requirements
- Participation in any other clinical trial (including observational trials) without
prior approval
- Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat,
emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the
excipients of E/C/F/TDF or E/C/F/TAF
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
drug: E/C/F/TDF Placebo
drug: E/C/F/TAF Placebo
drug: E/C/F/TAF
drug: E/C/F/TDF
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Debbie Slamowitz
650-723-2804