Clinical trial NCT02616783 (phase 3, status: completed)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: e/c/f/taf, tdf, ftc, ftc/tdf, 3tc, third agent
SMILES: [H][C@@](CO)(C(C)C)N1C=C(C(O)=O)C(=O)C2=C1C=C(OC)C(CC1=C(F)C(Cl)=CC=C1)=C2, [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C, NC1=NC(=O)N(C=C1F)[C@@H]1CS[C@H](CO)O1, [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C, NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1
Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently receiving a TDF and FTC or 3TC-containing 'backbone' (maximum 2 NRTIs)
             regimen plus a third agent for ≥ 6 consecutive months prior to screening visit. For
             individuals with 3 or more ART regimens, a regimen history must be provided for
             approval by the Sponsor.

        Refer to assigned interventions for allowed third agents of the current regimen.

          -  Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the
             screening visit (measured at least twice using the same assay). In the preceding 6
             months prior to screening, one episode of "blip" (HIV-1 RNA > 50 and < 400 copies/mL)
             is acceptable, only if HIV-1 RNA is < 50 copies/mL immediately before and after the
             "blip".

          -  Plasma HIV-1 RNA level < 50 copies/mL at screening visit

          -  Adequate renal function

          -  Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault
             formula (eGFRCG) and are on ARVs that are appropriately dose adjusted for renal
             function per package insert

          -  All documented historical plasma genotype(s) must not show resistance to TDF or FTC,
             including, but not limited to the presence of reverse transcriptase resistance
             mutations K65R, K70E, M184V/I, or thymidine analog-associated mutations (TAMs) that
             include M41L, L210W, D67N, K70R, T215Y/F, K219Q/E/N/R. If historical plasma prior to
             first ART is not available or individual has 3 or more ART regimens, individuals will
             have proviral genotype analysis prior to Day 1 to confirm absence of archived
             resistance to TDF or FTC.

          -  Study performed dual energy x-ray absorptiometry (DXA) scan and T-score received prior
             to Day 1

        Key Exclusion Criteria:

          -  Previous use of any approved or experimental integrase strand transfer inhibitor
             (INSTI) (for any length of time) if the current regimen contains a PI/r

          -  Individuals will have no evidence of previous virologic failure on a PI/r or
             INSTI-based regimen (with or without resistance to either class of ARV)

          -  A new AIDS-defining condition diagnosed within the 30 days prior to screening (except
             CD4+ cell count and/or percentage criteria)

          -  Hepatitis C virus that would require therapy during the study

          -  Individuals receiving ongoing treatment for bone disease (eg, osteoporosis), including
             bisphosphonates, denosumab, and strontium ranelate

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.