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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

Students Supervised

Type Name Title University Start Date End Date

Memberships

Role Committee/board Start Date End Date

Education

Institution Degree Year
,

Grants

Publications

Authors:
FERRE , VM
GBEASOR-KOMLANVI , AF
COLIN , G
DAGNRA , AC
Date:
2018-12-06
Journal:
Clin Infect Dis
Content:

Background:

Sub-Saharan Africa is a region of both high HIV and anal cancer incidence. We conducted the first national study in Togo to assess HPV, HIV and other Sexually Transmitted Infections (STIs) prevalence among Men having Sex with Men (MSM).

Methods:

A multicentric cross-sectional study was conducted among MSM recruited in four Togolese cities based on the respondent-driven sampling method. Socio-demographic characteristics and sexual behaviors were recorded using a standardized questionnaire. Anal swabs were collected to test HPV, HSV-1/2 and seven anal STIs. HIV, Syphilis and HBV were screened with rapid tests.

Results:

207 MSM were recruited, showing HIVand high-risk HPV (hrHPV) overall prevalence of 26.1% and 44.9%, respectively. Most common hrHPV types were HPV35 (15.0%) and HPV16 (13.0%). Prevalence of hrHPV and multiple HPV infections were higher among HIV-positive than among HIV-negative MSM (85.2% versus 30.7%, p<10-5 and 85.2% versus 28.7%, p<10-5, respectively). Other STIs, except HBV, were also more prevalent among HIV-positive MSM (N.gonorrhoeae, p=0.03; M.genitalium, p=0.04; HSV-2, p=0.001 and a trend for C.trachomatis, p=0.06). In multivariate analysis, HIV infection (aOR: 10.1, 95%CI: 4.0-25.6), living in Lomé (2.8, 1.1-7.1), HSV-2 anal excretion (26.7, 2.9-244.3), anal C.trachomatis (11.7, 2.3-58.9) and M.genitalium infection (9.6, 3.1-29.9) were associated with increased risk of anal hrHPV infection. All participants with anal N.gonorrhoeae infection were infected with at least one hrHPV.

Conclusions:

We report a high-burden of anal STIs with an unusual hrHPV types distribution among MSM, highlighting the critical need of implementation of a national strategy regarding prevention of STIs and vaccination against Papillomavirus

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