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 Details — Status: Completed

Administrative data

• NCT number: NCT00270530
• Other study ID #: S1954-21/22-2
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2005
• Last updated: January 30, 2006
• Start date: November 2002
• Est. completion date: October 2004

Study information

• Verified date: November 2004
• Source: Center for International Health and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

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

Related Conditions & MeSH terms

• HIV Infections
• HIV Seropositivity
• Infection
• Malaria
• Neonatal Deaths
• Placental Malaria Infection
• Prematurity
• Stillbirth

Intervention

Drug:
• Sulfadoxine-pyrimethamine (Fansidar)

Locations

Country	Name	City	State
Zambia	Tropical Diseases Research Centre	Ndola

Sponsors (2)

Lead Sponsor	Collaborator
Center for International Health and Development	Centers for Disease Control and Prevention

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Prevalence of placental malaria infection
Primary	• Prevalence of maternal peripheral parasitemia
Secondary	• Prevalence of maternal peripheral parasitemia
Secondary	• Birth weight, including the proportion of LBW infants
Secondary	• Incidence of prematurity
Secondary	• Neonatal and fetal death and third trimester stillbirth
Secondary	• Incidence of neonatal jaundice
Secondary	• Third trimester anemia
Secondary	• Third trimester severe anemia
Secondary	• Proportion of mothers who develop symptomatic malaria during the course of pregnancy