drugset / 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

NCT02605954

Phase 3 Completed 275 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-11-18
Primary completion
2017-06-14
Completion
2018-01-24

Publications

  • Background 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

Drugs

EvaluationDrugModalityDoseRoute
Comparator ABC/3TC Unknown 300 mg Oral
Comparator ABC/3TC Unknown 600 mg Oral
Subject E/C/F/TAF Unknown 10 mg Oral
Subject E/C/F/TAF Unknown 150 mg Oral
Subject E/C/F/TAF Unknown 200 mg Oral
Comparator Atazanavir Other / unclassified
Comparator Cobicistat Small molecule
Comparator Darunavir Small molecule
Comparator Dolutegravir Other / unclassified
Comparator Efavirenz Other / unclassified
Comparator Etravirine Small molecule
Comparator Fosamprenavir Small molecule
Comparator Lopinavir Other / unclassified
Comparator Nevirapine Small molecule
Comparator Raltegravir Other / unclassified
Comparator Rilpivirine Small molecule
Comparator Ritonavir Other / unclassified
Comparator Saquinavir Small molecule