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

Phase 3

Completed

Interventions: Drug: TDF
Drug: E/C/F/TAF
Drug: FTC
Drug: FTC/TDF
Drug: 3TC
Drug: Third agent

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Remain current regimen	TDF	Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
Remain current regimen	FTC/TDF	Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
Remain current regimen	Third agent	Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
E/C/F/TAF	E/C/F/TAF	Participants will switch from tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or 3TC plus a third agent to E/C/F/TAF and will receive treatment for 48 weeks.
Remain current regimen	FTC	Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
Remain current regimen	3TC	Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 48 in Spine BMD	Baseline; Week 48
Percent Change From Baseline to Week 48 in Hip BMD	Baseline; Week 48

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 24 in Spine BMD	Baseline; Week 24
Percent Change From Baseline to Week 24 in Hip BMD	Baseline; Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm	Week 24	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	Week 48	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Change From Baseline in CD4+ Cell Count at Week 24	Baseline; Week 24
Change in Baseline in CD4+ Cell Count at Week 48	Baseline; Week 48

Locations (35): CHU Saint-Pierre University Hospital
🇧🇪
Brussels, Belgium
University Hospital Gent
🇧🇪
Ghent, Belgium
CHU - Groupe Saint-Andre
🇫🇷
Bordeaux, France
CHU de Dijon
🇫🇷
Dijon, France
Hopital Europeen Marseille
🇫🇷
Marseille, France
C.H.U. de Nantes
🇫🇷
Nantes, France
C.H.U. de NICE
🇫🇷
Nice, France
Hopital Saint Louis
🇫🇷
Paris cedex 10, France
Hopital Saint Antoine
🇫🇷
Paris cedex 12, France
CHU Hotel Dieu
🇫🇷
Paris, France
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CHU Saint-Pierre University Hospital
🇧🇪Brussels, Belgium