Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Intervention: E/C/F/TAF; E/C/F/TDF; EFV/FTC/TDF; RTV; ATV; FTC/TDF; COBI
Intervention description: 150/150/200/10 mg FDC tablet administered orally once daily; 150/150/200/300 mg FDC tablet administered orally once daily; 600/200/300 mg FDC tablet administered orally once daily; 100 mg tablet administered orally once daily; 300 mg capsule administered orally once daily; 200/300 mg tablet administered orally once daily; 150 mg 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: None (Open Label)
Enrollment: 1443.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; HIV 1 Infected; Virologically-Suppressed

Summary:

      The primary objective of this study is to evaluate the non-inferiority of switching to a
      tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining
      tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically
      suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week
      48.
    

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

          -  Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF,
             RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months preceding the final
             visit in their earlier study

          -  Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103,
             GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only
             participants on an EFV-based regimen), or completion of studies GS-US-236-0104,
             GS-US-216-0105

          -  Plasma human immunodeficiency virus type 1-ribonucleic acid (HIV-1 RNA) concentrations
             at undetectable levels for at least 6 consecutive months prior to the screening visit
             and have HIV RNA < 50 copies/mL at the screening visit

          -  Normal echocardiograph (ECG)

          -  Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the
             Cockcroft-Gault formula for creatinine clearance

          -  Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase
             [ALT]) ≤ 5 × upper limit of the normal range (ULN)

          -  Direct bilirubin ≤ 1.5 x ULN

          -  Adequate hematologic function

          -  Serum amylase ≤ 5 × ULN

          -  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 12 weeks following the last dose of
             study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all
             other regimens.

          -  Female participants 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 participants 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 position

          -  Hepatitis C antibody positive

          -  Participants 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 subject 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 subject unsuitable for the study or unable to comply with
             dosing requirements

          -  Participation in any other clinical trial without prior approval from the sponsor is
             prohibited while participating in this trial

          -  Participants receiving ongoing therapy with drugs not to be used with elvitegravir
             (EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies
             to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.