CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 328 enrolled
Drug / intervention
emtricitabine 200mg/tenofovir 300mgdrug
Likely dose
emtricitabine 200mg/tenofovir 300mgfrom 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/NCT01781806
NCT01781806Phase 4Completed
CompareCT.gov

A Pilot Demonstration Project to Operationalize Pre-exposure Prophylaxis as Part of Combination HIV Prevention Among Men Who Have Sex With Men (MSM) and Transgender Women in Los Angeles County

University of California, Los Angeles·interventional·Posted Feb 1, 2013·Updated Apr 6, 2018

In Brief

A Phase 4 clinical trial evaluating emtricitabine 200mg/tenofovir 300mg for HIV Prevention. Completed, enrolled 328 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM and transgender women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Prevention
CountriesUnited States
CollaboratorsLos Angeles County Department of Public Health, Los Angeles LGBT Center, The OASIS Clinic, AIDS Project Los Angeles

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2013
Enrollment StartMay 1, 2013
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.4 years ago

Interventions

emtricitabine 200mg/tenofovir 300mgdrug

The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in creatinine clearance (CrCl) to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with CrCl \<30 mL/min, Truvada will be discontinued.