Study to Evaluate 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
Completed · Phase 3
Conditions studied: HIV-1 Infection
In brief
The primary objective of the study is to 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 (ARV) agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in human immunodeficiency virus (HIV) -1 reverse transcriptase. This is a two part study. 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.
Key facts
- Study ID
- NCT02616029
- Run by
- Gilead Sciences
- People needed
- 66
- Starts
- 2015-12-17
- Expected to finish
- 2019-07-11
- Last updated by the study team
- 2020-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Midway Immunology & Research Center, LLC — Ft. Pierce, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- Triple O Research Institute PA — West Palm Beach, Florida, United States
- Hopital Sainte Marguerite - Hospital — Marseille, France
- CHU de Nantes — Nantes, France
- CHU de Nice-l Archet — Nice, France
- CHR Orleans la Source — Orléans, France
- Hopital Saint Louis — Paris, France
- Hopital Necker les Enfants Malades — Paris, France
- CHU Tours Service de Médecine Internes et Maladies Infectieuses — Tours, France
- Universitatsklinikum Essen — Essen, Germany
- ICH Study Center- Dedicated Research — Hamburg, Germany
- Universitat Mainz — Mainz, Germany
- IRCCS A.O.U. San Martino — Genova, Italy
- Fondazione IRCCS San Raffaele del Monte Tabor — Milan, Italy
- ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco — Milan, Italy
- Comprensorio Amedeo Di Savoia Birago Di Vische — Torino, Italy
- Hospital Universitari Germans Trias i Pujol — Badalona, Spain
- Hospital Clinic de Barcelona - Hospital — Barcelona, Spain
- Hospital Universitario 12 de Octubre - Hospital — Madrid, Spain
- Hospital Universitario La Paz — Madrid, Spain
Full record on ClinicalTrials.gov
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