Status:
COMPLETED
Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
Lead Sponsor:
Center for International Health and Development
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Placental Malaria Infection
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival. Intermittent presumptive treatment with sulfad...
Detailed Description
Primary Objectives To compare the efficacy of IPT with monthly SP versus a two-dose regimen given once in the second and once in the third trimester in HIV-infected women on the: * Prevalence of pla...
Eligibility Criteria
Inclusion
- HIV-positive pregnant women between 16-28 weeks of gestation identified through VCT
- HIV-negative pregnant women between 16-28 weeks of gestation identified through VCT
- Residence within the catchment area of the health facility
- Willing to deliver at the health facility
- Willing to agree to adhere to the requirements of study participation (including monthly ANC visits and willing to allow all study procedures)
- Willing to provide written informed consent
- Aged 18 years and above
Exclusion
- Severe anemia (Hb \< 6 g/dL)
- History of allergic reactions to sulfa drugs
- History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section)
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization
- Any significant presenting illness that requires hospitalization
- Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area
- Prior enrollment in the study or concurrent enrollment in another study
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT00270530
Start Date
November 1 2002
End Date
October 1 2004
Last Update
January 31 2006
Active Locations (1)
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1
Tropical Diseases Research Centre
Ndola, Zambia