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
- Conditions
- HIV-1 Infection
- Interventions
- Registration Number
- NCT02616783
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (35)
Hopital Necker les Enfants Malades
🇫🇷Paris, France
University Hospital Gent
🇧🇪Ghent, Belgium
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Hopital Europeen Marseille
🇫🇷Marseille, France
C.H.U. de NICE
🇫🇷Nice, France
CHU de Dijon
🇫🇷Dijon, France
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
🇮🇹Roma, Italy
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
IRCCS A.O.U. San Martino
🇮🇹Genova, Italy
U.O. Malattie Infettive
🇮🇹Pescara, Italy
CHU - Groupe Saint-Andre
🇫🇷Bordeaux, France
CHU Saint-Pierre University Hospital
🇧🇪Brussels, Belgium
C.H.U. de Nantes
🇫🇷Nantes, France
Hopital Saint Louis
🇫🇷Paris cedex 10, France
Azienda Ospedaliero Universitaria Policlinico di Modena
🇮🇹Modena, Italy
Hopital Saint Antoine
🇫🇷Paris cedex 12, France
CHU Hotel Dieu
🇫🇷Paris, France
Hopital Haut-Leveque
🇫🇷Pessac, Cedex, France
Service des Maladies Infectieuses et du Voyageur
🇫🇷Tourcoing, France
Busto Arsizio Hospital
🇮🇹Busto Arsizio, Italy
Azienda Ospedaliera Luigi Sacco
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria di Sassari
🇮🇹Sassari, Italy
Dipartimento di Malattie Infettive e Tropicali
🇮🇹Torino, Italy
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Ramon Y Cajal University Hospital
🇪🇸Madrid, Spain
Hospital Costa Del Sol
🇪🇸Marbella, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Mortimer Market Centre
🇬🇧London, United Kingdom
Newcastle Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom