Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: E/C/F/TAF; ABC/3TC; Third Antiretroviral Agent
Intervention description: 150/150/200/10 mg FDC tablets administered orally once daily; 600/300 mg tablets administered orally once daily; Third antiretroviral agents could include one of the following:
ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC
DRV+COBI or DRV/COBI FDC
darunavir (DRV; Prezista®) + RTV
lopinavir/ritonavir (LPV/r; Kaletra®)
atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®)
efavirenz (EFV; Sustiva®)
etravirine (ETR; Intelence®)
nevirapine (NVP; Viramune®)
rilpivirine (RPV; Edurant®)
dolutegravir (DTG; Tivicay®)
raltegravir (RAL; Isentress®)
fosamprenavir (FPV; Lexiva®) + RTV
saquinavir (SQV; Invirase®) + RTV
ATV (no booster)
Drug classes:
Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV and SQV
Pharmacokinetic enhancer: COBI
Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR
Integrase inhibitors: RAL and DTG
Intervention MeSH terms: Anti-Retroviral Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV 1 Infection; HIV; Virologically-Suppressed; Antiretroviral agents

Summary:

      The primary objective of this study is to evaluate the efficacy of switching to
      elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose
      combination (FDC) relative to continuing on a baseline regimen consisting of
      abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in HIV-1 infected participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

        HIV-infected adult participants who meet the following criteria will be given the option to
        participate in the study:

          -  Currently receiving ABC/3TC plus a third antiretroviral (ARV) agent for ≥ 6
             consecutive months preceding the screening visit. For subjects with 3 or more ART
             regimens, a regimen history must be provided to the Sponsor for approval. Allowed
             third antiretroviral agents include LPV/r, ATV+RTV, ATV+COBI (or ATV/COBI FDC),
             DRV+RTV, DRV + COBI (or DRV/COBI FDC) FPV + RTV, SQV + RTV, ATV (no booster), EFV,
             RPV, NVP, ETR, RAL or DTG

          -  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 < 50 copies/mL at screening visit

          -  Individuals will have no evidence of previous virologic failure on a PI+RTV or
             integrase strand transfer inhibitor-based regimen (with or without resistance to
             either class of ARV).

          -  All documented historical plasma genotype(s) must not show resistance to tenofovir
             disoproxil fumarate (TDF) or emtricitabine (FTC), including, but not limited to the
             presence of reverse transcriptase resistance mutants K65R, K70E, M184V/I, or thymidine
             analog associated mutations (TAMs) (TAMs are: M41L, D67N, K70R, L210W, T215Y/F,
             K219Q/E/N/R). If a historical genotype is not available or subject has 3 or more ART
             regimens, subject will have proviral genotype analysis prior to Day 1 to confirm
             absence of archived resistance to TDF or FTC.

          -  Adequate renal function defined as having an estimated glomerular filtration rate of ≥
             30 mL/min as calculated by Cockcroft-Gault (eGFR-CG)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.