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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |