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
NCT ID: NCT02605954
Last Updated: 2018-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
275 participants
INTERVENTIONAL
2015-11-18
2018-01-24
Brief Summary
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Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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E/C/F/TAF
Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks.
E/C/F/TAF
150/150/200/10 mg FDC tablets administered orally once daily
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.
ABC/3TC
600/300 mg tablets administered orally once daily
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
Interventions
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E/C/F/TAF
150/150/200/10 mg FDC tablets administered orally once daily
ABC/3TC
600/300 mg tablets administered orally once daily
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Spectrum Medical Group
Phoenix, Arizona, United States
Ruane Clinical Research Group
Los Angeles, California, United States
Capital Medical Associates, P.C.
Washington D.C., District of Columbia, United States
Georgetown University
Washington D.C., District of Columbia, United States
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
Ft. 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
The Positive Health Clinic, Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Central Texas Clinical Research
Austin, Texas, United States
AIDS Arms, Inc./Trinity Health & Wellness Center
Dallas, Texas, United States
Tarrant County ID Associates
Fort Worth, Texas, United States
CHU - Groupe Saint-Andre
Bordeaux, , France
Hopital Henri Mondor
Créteil, , France
Hopital Europeen Marseille
Marseille, , France
C.H.U. de Nantes
Nantes, , France
C.H.U. de NICE
Nice, , France
CHU Hotel Dieu
Paris, , France
Hopital Lariboisiere
Paris, , France
Hopital Necker les Enfants Malades
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Saint Louis
Paris, , France
Centre Hospitalier Gustave Dron
Tourcoing, , France
Epimed GmbH
Berlin, , Germany
Universitatsklinikum Essen
Essen, , Germany
ICH Study Center Hamburg
Hamburg, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
ARNAS Garibaldi - Nesima
Catania, , Italy
Unit Infectious Diseases - University of Catania - ARNAS Garibaldi
Catania, , Italy
Azienda Ospedaliera Luigi Sacco
Milan, , 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
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
Mortimer Market Centre
London, , United Kingdom
Countries
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References
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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
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-002711-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-292-1823
Identifier Type: -
Identifier Source: org_study_id
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