Last updated on September 2018

Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I


Brief description of study

This two part study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in HIV-1 reverse transcriptase.

In Part 1, participants will have M184V and/or M184I (mixtures are acceptable) in reverse transcriptase without any other NRTI resistance mutation. If the rate of virologic failure in Part 1 is deemed acceptable, once the internal data monitoring committee officially completes the interim review, the study will continue to Part 2. In Part 2, participants will have M184V and/or M184I (mixtures are acceptable) in reverse transcriptase with or without 1 or 2 thymidine analog-associated mutations.

Clinical Study Identifier: NCT02616029

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Southern California Men's Medical Group
Los Angeles, CA United States

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Gary Richmond, MD, PA, Inc.
Fort Lauderdale, FL United States

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Midway Immunology & Research Center, LLC
Fort Pierce, FL United States

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Orlando Immunology Center
Orlando, FL United States

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Triple O Research Institute PA
West Palm Beach, FL United States

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Chatham County Health Department
Savannah, GA United States

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Southampton Healthcare, Inc.
Saint Louis, MO United States

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Southwest CARE Center
Santa Fe, NM United States

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Peter Shalit, MD
Seattle, WA United States

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Premier Clinical Research
Spokane, WA United States

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Hopital Sainte Marguerite - Hospital
Marseille, France

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CHU de Nantes
Nantes, France

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CHU de Nice-l Archet
Nice, France

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CHR Orleans la Source
Orleans, France

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Hopital Saint Louis
Paris Cedex 10, France

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CHU Hotel Dieu
Paris Cedex 14, France

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Hopital Necker les Enfants Malades
Paris Cedex 15, France

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Hopital Lariboisiere
Paris, France

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H pital Haut-L v que - Service M decine Interne
Pessac, France

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CHU Tours Service de M decine Internes et Maladies Infectieuses
Tours, France

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Universitatsklinikum Essen
Essen, Germany

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Infektiologikum Frankfurt
Frankfurt, Germany

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ICH Study Center- Dedicated Research
Hamburg, Germany

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Universitat Mainz
Mainz, Germany

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IRCCS A.O.U. San Martino
Genova, Italy

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Dipartimento di Malattie Infettive e Tropicali dell'Universit di Milano
Milano, Italy

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Fondazione IRCCS San Raffaele del Monte Tabor
Milano, Italy

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Universit degli Studi di Roma Tor Vergata
Roma, Italy

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Dipartimento di Malattie Infettive e Tropicali
Torino, Italy

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Hospital Universitari Germans Trias i Pujol
Badalona, Spain

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Hospital Clinic de Barcelona - Hospital
Barcelona, Spain

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Hospital Universitario 12 de Octubre - Hospital
Madrid, Spain

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Hospital Universitario La Paz
Madrid, Spain

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Hospital Regional Universitario De M laga
Malaga, Spain

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Hospital General Universitario de Valencia
Valencia, Spain

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Complexo Hospitalario Universitario De Vigo - Hospital Alvaro Cunqueiro Servicio de Medicina Interna
Vigo, Spain