Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: E/C/F/TAF; TDF; FTC; FTC/TDF; 3TC; Third agent
Intervention description: 150/150/200/10 mg FDC tablet administered orally once daily; 300 mg tablet administered orally once daily; 200 mg capsule administered orally once daily; 200/300 mg tablet administered orally once daily; Tablet administered orally; Third agent may include one of the following regimens: lopinavir+ritonavir (LPV/r; Kaletra®), atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®), ATV + cobicistat (COBI;Tybost®) (or ATV/COBI FDC), DRV + RTV, darunavir (DRV; Prezista®) + COBI (or DRV/COBI FDC), fosamprenavir (FPV; Lexiva®) + RTV , saquinavir (SQV; Invirase®; Fortovase®) + RTV, efavirenz (EFV;Sustiva®), rilpivirine (RPV;Edurant®), nevirapine (NVP;Viramune®), etravirine (ETR;Intelence®), raltegravir (RAL; Isentress®), elvitegravir (EVG) + COBI, or dolutegravir (DTG;Tivicay®)
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: Lamivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: HIV 1 Infection; HIV; Virologically-Suppressed

Summary:

      The primary objective of this study is to evaluate the safety of
      elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to
      unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral
      density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants
      aged ≥ 60 years.
    

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.