HIV Infections Clinical Trial
Official title:
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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