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Dr
Didier Ekouevi

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Profile EDCTP Fellowship 1

Project Title

Phase II multicentre open label trial to evaluate the pharmacokinetics and the safety and toxicity of the Tenofovir-Emtricitabine combination in pregnant women and infants in Africa and Asia

EDCTP Project

TA.2004.40200.003

EDCTP Program

EDCTP1

EDCTP Project Call

Senior Fellowship (SF)

Project Objectives

To assess safety, pharmacokinetics (PK) and resistance profile of Truvada® (tenofovir disporoxyl fumarate [TDF 300 mg] + Emtricitabine [FTC 200 mg]), an alternative ARV regimen for PMTCT in resource-limited settings in HIV-infected pregnant women and their infants

Study Design

Phase II Clinical Trial

Host Organisation

Department Institution Country
Centre Hospitalier Universitaire (CHU) de Treichville Cote D'ivoire

Sites

Results & Outcomes

This study laid a foundation for collaboration in prevention of motherto- child transmission trials between South Africa, Ivory Coast and Cambodia. The study showed that emtricitabine (FTC) achieves adequate blood levels in mothers and their neonates. Three publications have come out of the studies.