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

NCT00270530 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2006-01-31

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Sulfadoxine-pyrimethamine (Fansidar)

Sponsors & Collaborators

Principal Investigators

  • Davidson H Hamer, MD · Center for International Health and Development, Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Completion
2004-10-31

Countries

  • Zambia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00270530 on ClinicalTrials.gov