Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

Recruiting in Palo Alto (17 mi)

+116 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

Inclusion Criteria

Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures

Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis (PEP), up to 6 months prior to screening

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Treatment Details

Interventions

E/C/F/TAF (Antiretroviral)
E/C/F/TDF (Antiretroviral)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Open-Label Extension PhaseExperimental Treatment1 Intervention

After study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country.

Group II: E/C/F/TAF (Double-Blind Phase)Experimental Treatment2 Interventions

E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks

Group III: E/C/F/TDF (Double-Blind Phase)Active Control2 Interventions

E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks