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
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|ClinicalTrials.gov Identifier: NCT02616029|
Recruitment Status : Recruiting
First Posted : November 26, 2015
Last Update Posted : June 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Drug: E/C/F/TAF||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I|
|Actual Study Start Date :||December 17, 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||September 2019|
Participants will switch from their current regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF FDC and will receive treatment for 48 weeks.
E/C/F/TAF (150/150/200/10 mg) FDC tablets administered orally once daily
Other Name: Genvoya®
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 12 as defined by pure virologic response (PVR) [ Time Frame: Week 12 ]
- Proportion of participants with emergence of new mutations in HIV-1 reverse transcriptase and integrase [ Time Frame: Up to 48 weeks ]This outcome measure will be assessed with any post Day 1 sample with HIV-1 RNA ≥ 50 copies/mL.
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 using PVR [ Time Frame: Weeks 24 and 48 ]
- Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12, 24 and 48 using the FDA snapshot analysis [ Time Frame: Weeks 12, 24, and 48 ]
- Proportion of participants with CD4+ cell count change from Day 1 at Weeks 12, 24 and 48 [ Time Frame: Day 1, Weeks 12, 24, and 48 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616029
|Contact: Gilead Clinical Study Information Center||GileadClinicalTrials@gilead.com|
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|Study Director:||Gilead Study Director||Gilead Sciences|