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A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services

NCT01781806 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2018-04-06

Study results available
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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.

Conditions

  • HIV Prevention

Interventions

DRUG

emtricitabine 200mg/tenofovir 300mg

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.

Sponsors & Collaborators

  • Los Angeles County Department of Public Health

    collaborator OTHER_GOV

  • Los Angeles LGBT Center

    collaborator OTHER

  • The OASIS Clinic

    collaborator UNKNOWN

  • AIDS Project Los Angeles

    collaborator OTHER

  • University of California, Los Angeles

    lead OTHER

Principal Investigators

  • Raphael Landovitz, MD · University of California, Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-05-31
Completion
2016-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01781806 on ClinicalTrials.gov