study to evaluate the safety and efficacy of e/c/f/taf versus e/c/f/tdf in hiv-1 positive, antiretroviral treatment-naive adults

Conditions: HIV; HIV Infections

Summary: 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) in hiv-1 positive, antiretroviral treatment-naive adults.


Eligibility 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 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.

Keywords: hiv treatment naive hiv 1 infected women female