Clinical trial NCT02469246 (phase 3, status: completed)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: f/taf, abc/3tc, abc/3tc placebo, f/taf placebo, 3rd arv agent
SMILES: CC(C)OC(=O)[C@H](C)N[P@](=O)(CO[C@H](C)CN1C=NC2=C(N)N=CN=C12)OC1=CC=CC=C1, NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1, NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.