CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 41 enrolled
Drug / intervention
Genvoyadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03976752
NCT03976752Phase 1Completed
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Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens

Emory University·interventional·Posted Jun 6, 2019·Updated Aug 13, 2021

In Brief

A Phase 1 clinical trial evaluating Genvoya for HIV/AIDS. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This study is being conducted to determine if the uptake of anti-HIV medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartMar 13, 2019
Primary CompletionSep 20, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.1 years ago

Interventions

Genvoyadrug

Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.