CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Truvada +1 moredrug
Likely dose
Truvada 200 mgfrom 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/NCT02985996
NCT02985996Phase 1Completed
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Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities

Emory University·interventional·Posted Dec 7, 2016·Updated Sep 17, 2019

In Brief

A Phase 1 clinical trial evaluating Truvada and Genvoya for HIV Infections. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.

Study Details

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

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 7, 2016
Enrollment StartFeb 6, 2017
Primary CompletionNov 29, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.6 years ago

Interventions

Truvadadrug

Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.

Genvoyadrug

Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.