Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Condition: Acquired Immunodeficiency Syndrome; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: E/C/F/TDF; E/C/F/TAF Placebo; E/C/F/TAF; E/C/F/TDF Placebo
Intervention description: 150/150/200/300 mg FDC tablet administered orally once daily; Tablet administered orally once daily; 150/150/200/10 mg FDC tablet administered orally once daily; Tablet administered orally once daily
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 279.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; HIV; Treatment-Naive

Summary:

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

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability to understand and sign a written informed consent form

          -  Plasma HIV 1 RNA levels ≥ 5,000 copies/mL

          -  No prior use of any approved or experimental anti-HIV drug for any length of time

          -  Screening genotype report must show sensitivity to TDF and emtricitabine (FTC)

          -  Normal ECG

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to
             the Cockcroft Gault formula

          -  Hepatic transaminases ≤ 2.5 x upper limit of the normal range (ULN)

          -  Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

          -  Adequate hematologic function

          -  CD4+ cell count > 50 cells/µL

          -  Serum amylase ≤ 5 x ULN

          -  Normal thyroid-stimulating hormone (TSH)

          -  Females of childbearing potential must have a negative serum pregnancy test

          -  Females of childbearing potential must agree to utilize highly effective contraception
             methods from screening throughout the duration of study treatment and for 30 days
             following the last dose of study drugs

          -  Female subjects 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

          -  Female subjects who are postmenopausal must have documentation of cessation of menses
             for ≥ 12 months and hormonal failure

          -  Female subjects 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 test at screening

          -  Male subjects must agree to utilize a highly effective method of contraception during
             heterosexual intercourse throughout the study period and for 90 days following
             discontinuation of investigational medicinal product

          -  Age ≥ 18 years

          -  Life expectancy ≥ 1 year

        Key Exclusion Criteria:

          -  New AIDS-defining condition diagnosed within the 30 days prior to screening

          -  Hepatitis B surface Antigen positive

          -  Hepatitis C Antibody positive

          -  Proven acute hepatitis in the 30 days prior to study entry

          -  Subjects experiencing decompensated cirrhosis

          -  Females who are breastfeeding

          -  Positive serum pregnancy test (female of childbearing potential)

          -  Have an implanted defibrillator or pacemaker

          -  Receiving ongoing therapy with any of the disallowed medications, including drugs not
             to be used with elvitegravir and cobicistat

          -  Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3
             months of study screening, or expected to receive these agents or systemic steroids
             during the study

          -  Current alcohol or substance

          -  History of or ongoing malignancy (including untreated carcinoma in-situ) other than
             cutaneous Kaposi's sarcoma (KS), basal cell carcinoma or resected, non-invasive
             cutaneous squamous carcinoma

          -  Active, serious infections (other than HIV 1 infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to Baseline

          -  Participation in any other clinical trial without prior approval is prohibited while
             participating in this trial

          -  Medications contraindicated for use with emtricitabine or tenofovir disoproxil
             fumarate

          -  Any known allergies to the excipients of E/C/F/TAF or E/C/F/TDF FDC tablets

          -  Any other clinical condition or prior therapy that would make the subject unsuitable
             for the study or unable to comply with the dosing requirements

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.