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
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Intervention: E/C/F/TAF; E/C/F/TDF; E/C/F/TDF Placebo; E/C/F/TAF Placebo
Intervention description: 150/150/200/10 mg FDC tablet administered orally once daily; 150/150/200/300 mg FDC tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 872.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Treatment Naive; HIV 1 Infected; Women; Female

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.