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

Phase 4

Completed

• Conditions: Placental Malaria Infection; HIV Infections; Stillbirth; Prematurity; Neonatal Deaths

• Registration Number: NCT00270530
• Lead Sponsor: Center for International Health and Development

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 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.

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 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 Timeline

• Study Start: 2002-11
• Study Completion: 2004-10
• Status Verified: 2004-11
• Study First Submitted: 2005-12-23
• Study First Submitted QC: 2005-12-23
• Study First Posted: 2005-12-28
• Last Update Submitted: 2006-01-30
• Last Update Posted: 2006-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 454

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
• Prevalence of placental malaria infection
• Prevalence of maternal peripheral parasitemia

Secondary Outcome Measures

Name	Time	Method
• Prevalence of maternal peripheral parasitemia
• 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

Trial Locations

Locations (1)

Tropical Diseases Research Centre; 🇿🇲 Ndola, Zambia