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Clinical Trial Summary

This open-label, multicenter study is to evaluate switching from optimized antiretroviral (ARV) regimens to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus darunavir (DRV) relative to current antiretroviral regimens (ARV), and to evaluate the efficacy, safety, and tolerability of the E/C/F/TAF STR+DRV in virologically suppressed, HIV-1 positive participants.

- Cohort 1: 20 participants will receive E/C/F/TAF STR+DRV once daily. At Week 4, safety and efficacy data from the 20 subjects in Cohort 1 will be reviewed prior to randomizing additional subjects in Cohort 2. Cohort 1 subjects will continue treatment with E/C/F/TAF plus DRV for a total of 48 weeks.

- Cohort 2: 150 participants will be randomized in a 2:1 ratio to receive E/C/F/TAF STR+DRV once daily, or remain on their current, pre-existing, ARV regimen.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01968551
Study type Interventional
Source Gilead Sciences
Contact
Status Completed
Phase Phase 3
Start date September 2013
Completion date June 2016

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