Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02605954

First received: November 13, 2015
Last updated: October 19, 2018
Last Verified: June 2018
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV-1 Infection

Drug : E/C/F/TAF
Drug : ABC/3TC
Drug : Third Antiretroviral Agent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24 [ Time Frame: 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:
  • Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline; Week 24 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]

Enrollment: 275
Study Start Date: November 18, 2015
Study Completion Date: January 24, 2018
Primary Completion Date: June 14, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: E/C/F/TAF
Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks.
Drug: E/C/F/TAF

150/150/200/10 mg FDC tablets administered orally once daily

Other Name: Genvoya®
Active Comparator: ABC/3TC+3rd 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.
Drug: ABC/3TC

600/300 mg tablets administered orally once daily

Other Name:
  • Epzicom
  • Kivexa

Drug: Third Antiretroviral Agent
    Third antiretroviral agents could include one of the following:
    • ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC
    • DRV+COBI or DRV/COBI FDC
    • darunavir (DRV; Prezista®) + RTV
    • lopinavir/ritonavir (LPV/r; Kaletra®)
    • atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®)
    • efavirenz (EFV; Sustiva®)
    • etravirine (ETR; Intelence®)
    • nevirapine (NVP; Viramune®)
    • rilpivirine (RPV; Edurant®)
    • dolutegravir (DTG; Tivicay®)
    • raltegravir (RAL; Isentress®)
    • fosamprenavir (FPV; Lexiva®) + RTV
    • saquinavir (SQV; Invirase®) + RTV
    • ATV (no booster)
    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

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    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.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02605954

    Locations

    United States, Arizona
    Spectrum Medical Group
    Phoenix, Arizona, United States
    United States, California
    Ruane Clinical Research Group
    Los Angeles, California, United States, 90036
    United States, District of Columbia
    Capital Medical Associates, P.C.
    Washington, District of Columbia, United States
    Georgetown University
    Washington, District of Columbia, United States
    United States, Florida
    Gary Richmond, MD, PA, Inc.
    Fort Lauderdale, Florida, United States
    Midway Immunology & Research Center, LLC
    Fort Pierce, Florida, United States
    Steinhart Medical Associates dba The Kinder Medical Group
    Miami, Florida, United States
    Triple O Research Institute PA
    West Palm Beach, Florida, United States
    United States, Pennsylvania
    The Positive Health Clinic, Allegheny Health Network
    Pittsburgh, Pennsylvania, United States
    United States, Texas
    Central Texas Clinical Research
    Austin, Texas, United States, 78705
    AIDS Arms, Inc./Trinity Health & Wellness Center
    Dallas, Texas, United States, 75208
    Tarrant County ID Associates
    Fort Worth, Texas, United States, 76104
    France
    CHU - Groupe Saint-Andre
    Bordeaux, France
    Hopital Henri Mondor
    Creteil, 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 Cedex 14, France
    Hopital Lariboisiere
    Paris, France
    Hopital Necker les Enfants Malades
    Paris, France
    Centre Hospitalier Gustave Dron
    Tourcoing, France
    Germany
    Epimed GmbH
    Berlin, Germany
    Universitatsklinikum Essen
    Essen, Germany
    ICH Study Center Hamburg
    Hamburg, Germany
    Universitatsklinikum Hamburg-Eppendorf
    Hamburg, Germany
    Italy
    ARNAS Garibaldi - Nesima
    Catania, Italy
    Unit Infectious Diseases - University of Catania - ARNAS Garibaldi
    Catania, Italy
    Azienda Ospedaliera Luigi Sacco
    Milano, Italy
    Azienda Ospedaliero Universitaria Policlinico di Modena
    Modena, Italy
    Azienda Ospedale San Paolo
    Monza, Italy
    Azienda Ospedaliera San Gerardo
    Monza, Italy
    Ospedale Civile S. Spirito AUSL
    Pescara, Italy
    Unità Operativa Complessa di Malattie Infettive
    Pescara, Italy
    Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
    Roma, Italy
    Comprensorio Ospedaliero Amedeo di Savoia
    Torino, Italy
    Dipartimento di Malattie Infettive e Tropicali
    Torino, Italy
    Spain
    Hospital Clinic de Barcelona
    Barcelona, Spain
    Hospital de la Santa Creu i Sant Pau
    Barcelona, Spain
    Hospital Universitari Vall d'Hebron
    Barcelona, Spain
    Hospital General Universitario Gregorio Maranon
    Madrid, Spain
    Hospital Universitario 12 de Octubre
    Madrid, Spain
    Hospital Costa Del Sol
    Marbella, Spain
    Hospital Reg. Univ. Carlos Haya
    Málaga, Spain
    Hospital Clínico Universitario de Valencia (Galindo)
    Valencia, Spain
    Hospital General Universitario de Valencia (Abril)
    Valencia, Spain
    Hospital Alvaro Cunqueiro
    Vigo, Spain
    United Kingdom
    Mortimer Market Centre
    London, United Kingdom

    Sponsors and Collaborators

    Gilead Sciences

    Investigators

    Study Director: Gilead Study Director Gilead Sciences
    More Information

    More Information


    Responsible Party: Gilead Sciences  
    ClinicalTrials.gov Identifier: NCT02605954   History of Changes  
    Other Study ID Numbers: GS-US-292-1823  
      2015-002711-15  
    Study First Received: November 13, 2015  
    Last Updated: October 19, 2018  
    Individual Participant Data    
    Plan to Share IPD: Yes  

    Studies a U.S. FDA-regulated Drug Product: Yes  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by Gilead Sciences:

    HIV 1 Infection
    HIV
    Virologically-Suppressed
    Antiretroviral agents

    Additional relevant MeSH terms:
    Infection
    Anti-Retroviral Agents
    Genvoya

    ClinicalTrials.gov processed this data on June 01, 2020
    This information is provided by ClinicalTrials.gov.