Status:
COMPLETED
Prevention of Pregnancy-associated Malaria in HIV-infected Women: Cotrimoxazole Prophylaxis Versus Mefloquine
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
Sidaction
Saint Antoine University Hospital
Conditions:
Malaria in Pregnancy
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of cotrimoxazole prophylaxis in prevention of malaria during pregnancy in HIV-infected women, compared to intermittent preventive treatment with m...
Detailed Description
Malaria infection during pregnancy can have adverse effects on both mother and fetus, including maternal anaemia and low birth weight which are responsible for mother and infant mortality. It is a par...
Eligibility Criteria
Inclusion
- Confirmed HIV seropositivity
- Permanent residency in the study catchment's area
- Confirmed pregnancy, gestational age\< 28 weeks
- More than 18 years of age
- Karnofsky index ≥80
- Willingness to deliver at the hospital
- Written informed consent
Exclusion
- History of allergy to study drugs : sulpha drugs, mefloquine, quinine
- History or presence of major illnesses : severe renal disease , severe hepatic disease, severe neuropsychiatric disease
- Mefloquine or halofantrine received within the 4 weeks prior to enrolment
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00970879
Start Date
December 1 2009
End Date
December 1 2012
Last Update
January 23 2013
Active Locations (5)
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1
Hôpital d'Instruction des Armées Camp Guézo
Cotonou, Benin
2
Hôpital de la Mère et de l'Enfant Lagune
Cotonou, Benin
3
Hôpital de zone de Suru Lere
Cotonou, Benin
4
Unviversity Hospital Hubert Koutoukou Maga
Cotonou, Benin