Birmingham, Alabama 35294

  • HIV Infections

Purpose:

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.


Criteria:

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 disoproxil fumarate (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 Key Exclusion Criteria: - A new acquired immunodeficiency syndrome (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 - Individuals receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets Note: Other protocol defined Inclusion/Exclusion criteria may apply.


NCT ID:

NCT01780506


Primary Contact:

Study Director
Gilead Study Director
Gilead Sciences


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 30, 2021

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