Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
Condition: HIV-1 Infection
Intervention: F/TAF; ABC/3TC; ABC/3TC Placebo; F/TAF Placebo; 3rd ARV agent
Intervention description: 200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily; 600/300 mg FDC tablets administered orally once daily; Tablets administered orally once daily; Tablets administered orally once daily; An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP).
Intervention MeSH terms: Lamivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; HIV-1 Positive; Virologically-Suppressed

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to
      emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human
      immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on
      regimens containing ABC/3TC.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The ability to understand and sign a written informed consent form

          -  On antiretroviral regimen containing ABC/3TC FDC in combination with one 3rd agent for
             ≥ 6 consecutive months prior to screening

          -  Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit
             (measured at least twice using the same assay) and without experiencing two
             consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two
             consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year

          -  Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit

          -  Normal ECG

          -  Estimated glomerular filtration rate (GFR) ≥ 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

          -  Females of childbearing potential and males 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

        Key Exclusion Criteria:

          -  A new AIDS-defining condition diagnosed within the 30 days prior to screening

          -  Hepatitis B surface antigen (HBsAg) positive

          -  Individuals experiencing decompensated cirrhosis

          -  Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg,
             osteoporosis)

          -  Pregnant or lactating females

          -  Have an implanted defibrillator or pacemaker

          -  Current alcohol or substance use judged by the investigator to potentially interfere
             with study compliance

          -  A history of malignancy within the past 5 years (prior to screening) or ongoing
             malignancy 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 Day 1 Visit

          -  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

          -  Medications excluded due to the potential for interaction with emtricitabine (FTC),
             TAF, ABC or 3TC

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.