Overview

This trial is active, not recruiting.

Condition hiv prevention
Treatment emtricitabine 200mg/tenofovir 300mg
Phase phase 4
Sponsor University of California, Los Angeles
Collaborator Los Angeles County Division of HIV and STD Programs
Start date May 2013
End date April 2017
Trial size 375 participants
Trial identifier NCT01781806, EI11-LA-002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis). High Risk Cohort Criteria (one or more of the following has to be met): No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months. STI diagnosis during the last 12 months. Previous PEP use during the last 12 months (* see exclusion criteria) Has at least one HIV infected sexual partner for ≥4 weeks.
emtricitabine 200mg/tenofovir 300mg Truvada
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 CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.
(Active Comparator)
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
emtricitabine 200mg/tenofovir 300mg Truvada
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 CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.

Primary Outcomes

Measure
Safety: Adverse events/Serious Adverse Events
time frame: Baseline to 48 weeks

Secondary Outcomes

Measure
Adherence to daily FTC/Tenofovir
time frame: Baseline to 48 weeks

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - At least 18 years of age - Able to understand and provide consent in English or Spanish - Self identified MSM, MSM/W, or Transgender (MTF) - At least one male sex partner for anal intercourse in the prior 12 months - HIV negative by EIA and VL - Creatinine clearance ≥ 60 ml/min (via Cockcroft-Gault formula) - No signs or symptoms suggestive of primary HIV infection (PHI). Exclusion Criteria: - Participants <18 years of age - Unable to understand and provide consent in English or Spanish - Known or found on testing to be HIV positive - Any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PEP or PrEP medication dosing - Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within 60 days of study entry - Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded. - Signs or symptoms suspicious for PHI.

Additional Information

Official title A Pilot Demonstration Project to Operationalize Pre-exposure Prophylaxis as Part of Combination HIV Prevention Among MSM and Transgender Women in Los Angeles County
Principal investigator Raphael Landovitz, MD
Description Two community-based sites (Los Angeles Gay and Lesbian Center [LAGLC] and The OASIS Clinic) will serve as facilities at which participants may present for screening for prevention services. At the sites, eligibility criteria will be assessed, HIV, STD and laboratory testing will be performed, and HIV prevention service referrals will be initiated. Follow-up will be on a monthly basis for the first three months, and then de-escalated to an every-3-month interval. The program stratifies participants into two cohorts on the basis of sexual risk behavior: a low-moderate risk cohort (LM) and a high-risk cohort (H). Participants in the LM cohort will be provided a customized prevention package (CPP) including access to post-exposure prophylaxis (PEP) for emergency HIV prevention in the event of unanticipated HIV exposure. Participants in the H cohort will be provided a CPP including daily Truvada-based PrEP. All participants will be followed for 48 weeks. Participants in the LM cohort who, on longitudinal sexual risk behavior surveillance, report increased levels of sexual risk-taking such that they meet enrollment criteria for the H-cohort will be transitioned to the H-cohort. At each follow-up visit, a careful safety assessment will be made, including signs/symptoms and laboratory assessments. STI testing will be performed at 3 month intervals. An escalating-intensity adherence intervention will be implemented based on real-time serum tenofovir levels. A computer-assisted self-interview (CASI) will be used to capture detailed sexual risk, adherence, and substance use behavior.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.