Clinical trial NCT02605954: 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
Official title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) Plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1 Infection
Keywords: HIV 1 Infection
HIV
Virologically-Suppressed
Antiretroviral agents
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48
timeFrame: Week 48
measure: Change From Baseline in CD4+ Cell Count at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in CD4+ Cell Count at Week 48
timeFrame: Baseline; Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Spectrum Medical Group
state: Arizona
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group
state: California
city: Washington
country: United States
facility: Capital Medical Associates, P.C.
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Gary Richmond, MD, PA, Inc.
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology & Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Steinhart Medical Associates dba The Kinder Medical Group
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute PA
state: Florida
city: Pittsburgh
country: United States
facility: The Positive Health Clinic, Allegheny Health Network
state: Pennsylvania
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: AIDS Arms, Inc./Trinity Health & Wellness Center
state: Texas
city: Fort Worth
country: United States
facility: Tarrant County ID Associates
state: Texas
city: Bordeaux
country: France
facility: CHU - Groupe Saint-Andre
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Marseille
country: France
facility: Hopital Europeen Marseille
city: Nantes
country: France
facility: C.H.U. de Nantes
city: Nice
country: France
facility: C.H.U. de NICE
city: PARIS cedex 10
country: France
facility: Hopital Saint Louis
city: Paris cedex 12
country: France
facility: Hopital Saint Antoine
city: Paris Cedex 14
country: France
facility: CHU Hotel Dieu
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Necker les Enfants Malades
city: Tourcoing
country: France
facility: Centre Hospitalier Gustave Dron
city: Berlin
country: Germany
facility: Epimed GmbH
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Hamburg
country: Germany
facility: ICH Study Center Hamburg
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendorf
city: Catania
country: Italy
facility: ARNAS Garibaldi - Nesima
city: Catania
country: Italy
facility: Unit Infectious Diseases - University of Catania - ARNAS Garibaldi
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico di Modena
city: Monza
country: Italy
facility: Azienda Ospedale San Paolo
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Pescara
country: Italy
facility: Ospedale Civile S. Spirito AUSL
city: Pescara
country: Italy
facility: Unità Operativa Complessa di Malattie Infettive
city: Roma
country: Italy
facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
city: Torino
country: Italy
facility: Comprensorio Ospedaliero Amedeo di Savoia
city: Torino
country: Italy
facility: Dipartimento di Malattie Infettive e Tropicali
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Marbella
country: Spain
facility: Hospital Costa Del Sol
city: Málaga
country: Spain
facility: Hospital Reg. Univ. Carlos Haya
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia (Galindo)
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia (Abril)
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: London
country: United Kingdom
facility: Mortimer Market Centre
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: A Gori, G Rizzardini, C Miralles, J Olalla, JM Molina, F Raffi, P Kumar, A Antinori, M Ramgopal, HJ Stellbrink, M Das, H Chu, R Ram, W Garner, SK Chuck, D Piontkowsky, R Haubrich. Switching from An Abacavir (ABC)/Lamivudine (3TC)-Based Regimen to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) is Efficacious and Safe: Week 24 Primary Analysis of a Randomized Controlled Study in Virologically-Suppressed Adults [Presentation]. XVIII Congrès National de la SFLS, 19-20 October 2017, Nice Acropolis, France