EDCTP Alumni Network

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All Profiles
Call Senior Fellowship (SF)
Programme EDCTP1
Start Date 2005-01-01
End Date 2007-10-30
Project Code TA.2004.40200.003
Status Completed

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

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

Host Organisation

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

Participants

Name Institution Country
Gerard Allou Centre Hospitalier Universitaire (CHU) de Treichville Cote D'ivoire
Patricia Fassinou Centre Hospitalier Universitaire (CHU) de Treichville Cote D'ivoire
Appolinaire Horo Centre Hospitalier Universitaire (CHU) de Treichville Cote D'ivoire
Hassan Toure Centre Hospitalier Universitaire (CHU) de Treichville Cote D'ivoire
Ida Viho Centre Hospitalier Universitaire (CHU) de Treichville Cote D'ivoire

Study Design

Phase II Clinical Trial

Sites

Centre Hospitalier Universitaire (CHU) de Treichville (Cote d’Ivoire)

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.

Publications

The TEmAA ANRS 12109 Study group. Tolerance and viral resistance after single-dose nevirapine with tenofovir and emtricitabine to prevent vertical transmission of HIV-1. AIDS. 2009; 23(7):825-33
Hirt D, Urien S, Ekouévi DK, Rey E, Arrivé E, Blanche S, Amani-Bosse C, Nerrienet E, Gray G, Kone M, Leang SK, McIntyre J, Dabis F, Tréluyer JM. Population Pharmacokinetics of Tenofovir in HIV-1-Infected Pregnant Women and Their Neonates (ANRS 12109). Clinical pharmacology & Therapeutics. 2008 Nov 5; 1-5
Hirt D, Urien S, Rey E, Arrive E, Ekouevi DK, Coffie P, Leang SK, Lalsab S, Avit D, Nerrienet E, McIntyre J, Blanche S, Dabis F, Treluyer, JM. Population Pharmacokinetics of Emtricitabine in Human Immunodeficiency Virus Type 1-Infected Pregnant Women and Their Neonates. Antimicrobial agents and chemotherapy. 2009 March;53(3);1067-1073

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