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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Placental Malaria Infection, HIV Infections, Stillbirth, Prematurity, Neonatal Deaths

Intervention / Treatment
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* Drug: Sulfadoxine-pyrimethamine (Fansidar)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfadoxine-pyrimethamine (Fansidar)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Prevalence of placental malaria infection |  |  | 
| • Prevalence of maternal peripheral parasitemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, Placental diseases, Birth complications, Plasmodium falciparum, Zambia, HIV-seropositive, HIV