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Status
Ongoing
Phase
Open Label
Principal Investigator(s)
Beatriz Grinsztejn
Objective
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.
**Preliminary results presented in July 2015 show high uptake of PrEP, with higher uptake among those at increased risk and with an existing awareness of PrEP.**
Prevention Option(s)
PrEP
Study Design
Open label
Arms and Assigned Interventions
Description
Fixed dose combination of emtricitabine (FTC) / tenofovir (TDF) (200/300 mg) once daily orally
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
Trial Sponsors
University of Sao Paulo; Centro de Referência e Treinamento DST AIDS; Oswaldo Cruz Foundation
Product Developers
University of Sao Paulo; Centro de Referência e Treinamento DST AIDS; Oswaldo Cruz Foundation
October 2014
January 2016
Enrollment
460
18
Years
Population
MSM
Sites
Instituto de Pesquisa Clínica Evandro Chagas
Rio de Janeiro
Brazil
Centro de Referência e Treinamento
Sao Paulo
Brazil
University of Sao Paulo - Hospital das Clínicas da Faculdade de Medicina da USP
Sao Paulo
Brazil