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

HIV Infections Clinical Trial

Official title:
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia

Clinical Trial 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.

Clinical Trial 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 placental malaria infection

- Prevalence of maternal peripheral parasitemia

Secondary objectives

To compare 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:

- Birth weight, including the proportion of LBW infants

- Incidence of prematurity

- Neonatal and fetal death and third trimester stillbirth

- Incidence of neonatal jaundice

- Third trimester anemia

- Third trimester severe anemia

- Proportion of mothers who develop symptomatic malaria during the course of pregnancy ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00270530
Study type Interventional
Source Center for International Health and Development
Contact
Status Completed
Phase Phase 4
Start date November 2002
Completion date October 2004
View Details
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