Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
