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 : July 9, 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|