drugset / Trial / NCT00270530

Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia

NCT00270530 ↗

RandomizedFactorialDouble-blindTreatment

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 sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. However, based on a study done in western Kenya, HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as HIV appears to reduce the effectiveness of the SP drug combination. The goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP dosing schedule in HIV-positive women.

Timeline

Start
2002-11
Primary completion
—
Completion
2004-10

Outcome

Missed primary endpoint

paper monthly SP IPTp was not more efficacious than the standard 2-dose regimen for the prevention of placental malaria or adverse birth outcomes. PMID 18008241 ↗

paper There were no differences between monthly IPTp (n=224) and standard IPTp (n=232) in placental malaria by histopathology (26% vs. 29%; relative risk [RR], 0.90 [95% confidence interval {CI}, 0.64-1.26]) PMID 18008241 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sulfadoxine-pyrimethamine Small molecule — —