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Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.

NCT01989611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-10-12

No results posted yet for this study

Summary

A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) administered orally, once daily, to MSM and transgender women . The demonstration project aims to include 400 participants over 12 months, with 200 at IPEC-Fiocruz, 100 at CRT-SP and 100 at USP.

Conditions

Interventions

DRUG

emtricitabine / tenofovir 200/300 mg

Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Centro de Referência e Treinamento DST/Aids

    collaborator OTHER_GOV

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • Beatriz Grinsztejn, PhD · Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT01989611 on ClinicalTrials.gov