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
- Conditions
- HIV-1 Infection
- Interventions
- Registration Number
- NCT02605954
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E/C/F/TAF E/C/F/TAF Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks. ABC/3TC+3rd Agent Third Antiretroviral Agent Participants will maintain prior regimen of ABC/3TC plus a third antiretroviral agent for 24 weeks followed by a delayed switch to E/C/F/TAF FDC. Note: the prior regimen is determined by the participant's clinician (prior to entry into the study) and will consist of one of the third antiretroviral agents listed. ABC/3TC+3rd Agent ABC/3TC Participants will maintain prior regimen of ABC/3TC plus a third antiretroviral agent for 24 weeks followed by a delayed switch to E/C/F/TAF FDC. Note: the prior regimen is determined by the participant's clinician (prior to entry into the study) and will consist of one of the third antiretroviral agents listed.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24 Week 24 The percentage of participants achieving 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in CD4+ Cell Count at Week 48 Baseline; Week 48 Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12 Week 12 The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at week 12 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 Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48 Week 48 The percentage of participants achieving 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
Trial Locations
- Locations (49)
Capital Medical Associates, P.C.
🇺🇸Washington, District of Columbia, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Azienda Ospedale San Paolo
🇮🇹Monza, Italy
Hopital Europeen Marseille
🇫🇷Marseille, France
Tarrant County ID Associates
🇺🇸Fort Worth, Texas, United States
ICH Study Center Hamburg
🇩🇪Hamburg, Germany
ARNAS Garibaldi - Nesima
🇮🇹Catania, Italy
Unit Infectious Diseases - University of Catania - ARNAS Garibaldi
🇮🇹Catania, Italy
Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
Hopital Necker les Enfants Malades
🇫🇷Paris, France
CHU - Groupe Saint-Andre
🇫🇷Bordeaux, France
Epimed GmbH
🇩🇪Berlin, Germany
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
🇮🇹Roma, Italy
Universitatsklinikum Essen
🇩🇪Essen, Germany
Hopital Henri Mondor
🇫🇷Creteil, France
Azienda Ospedaliero Universitaria Policlinico di Modena
🇮🇹Modena, Italy
C.H.U. de NICE
🇫🇷Nice, France
Hopital Saint Louis
🇫🇷PARIS cedex 10, France
Comprensorio Ospedaliero Amedeo di Savoia
🇮🇹Torino, Italy
Dipartimento di Malattie Infettive e Tropicali
🇮🇹Torino, Italy
C.H.U. de Nantes
🇫🇷Nantes, France
Hopital Saint Antoine
🇫🇷Paris cedex 12, France
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Azienda Ospedaliera Luigi Sacco
🇮🇹Milano, Italy
Ospedale Civile S. Spirito AUSL
🇮🇹Pescara, Italy
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Costa Del Sol
🇪🇸Marbella, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Spain
Steinhart Medical Associates dba The Kinder Medical Group
🇺🇸Miami, Florida, United States
Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States
Unità Operativa Complessa di Malattie Infettive
🇮🇹Pescara, Italy
CHU Hotel Dieu
🇫🇷Paris Cedex 14, France
Centre Hospitalier Gustave Dron
🇫🇷Tourcoing, France
Hospital Reg. Univ. Carlos Haya
🇪🇸Málaga, Spain
Ruane Clinical Research Group
🇺🇸Los Angeles, California, United States
Gary Richmond, MD, PA, Inc.
🇺🇸Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
🇺🇸Fort Pierce, Florida, United States
Triple O Research Institute PA
🇺🇸West Palm Beach, Florida, United States
The Positive Health Clinic, Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
AIDS Arms, Inc./Trinity Health & Wellness Center
🇺🇸Dallas, Texas, United States
Universitatsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Hospital Clínico Universitario de Valencia (Galindo)
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia (Abril)
🇪🇸Valencia, Spain
Mortimer Market Centre
🇬🇧London, United Kingdom
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Hopital Lariboisiere
🇫🇷Paris, France