CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 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/NCT00856323
NCT00856323Phase 2Completed
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Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM

Friends Research Institute, Inc.·interventional·Posted Mar 5, 2009·Updated Sep 20, 2016

In Brief

A Phase 2 clinical trial evaluating Truvada and CM for Amphetamine-Related Disorders and 2 related conditions. Completed, enrolled 53 participants across 1 site.

Detailed Summary

This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors among methamphetamine-using men who have sex with men (MSM) by combining a biomedical intervention with a behavioral intervention. The behavioral intervention will consist of an 8-week course of contingency management (CM) through which participants will be reinforced for testing negative for methamphetamine metabolites during periodic urine analyses. The biomedical intervention involves a 28-day course of an antiretroviral drug (Truvada) to be administered after an unanticipated HIV risk exposure (i.e., engaging in either receptive or insertive anal sex without a condom with someone who is HIV-positive or of unknown status). In combining these two interventions, this study seeks to evaluate the combined intervention's effects on sexual risk behaviors and methamphetamine use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmphetamine-Related Disorders, HIV, HIV Infections
CountriesUnited States
CollaboratorsUniversity of California, Los Angeles

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2009
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.3 years ago

Interventions

Truvadadrug

At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).

CMbehavioral

Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites.