skip to content

Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Center for International Health and Development

Collaborator
Centers for Disease Control and Prevention

Information provided by (Responsible Party)
Center for International Health and Development
ClinicalTrials.gov Identifier
NCT00270530

First received: December 23, 2005
Last updated: January 30, 2006
Last Verified: November 2004
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Placental Malaria Infection
HIV Infections
Stillbirth
Prematurity
Neonatal Deaths

Drug : Sulfadoxine-pyrimethamine (Fansidar)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia

Further study details as provided by Center for International Health and Development:

Primary Outcome Measures

  • • Prevalence of placental malaria infection
  • • Prevalence of maternal peripheral parasitemia
Secondary Outcome Measures:
  • • 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

Enrollment: 454
Study Start Date: November 2002
Study Completion Date: October 2004

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
  • tion of mothers who develop symptomatic malaria during the course of pregnancy

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years to 50 Years  
    Sexes Eligible for Study: Female  
    Accepts Healthy Volunteers: No  

    Criteria

    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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00270530

    Locations

    Zambia
    Tropical Diseases Research Centre
    Ndola, Zambia

    Sponsors and Collaborators

    Center for International Health and Development
    Centers for Disease Control and Prevention

    Investigators

    Principal Investigator: Davidson H Hamer, MD Center for International Health and Development, Boston University
    More Information

    More Information


    Responsible Party: Center for International Health and Development  
    ClinicalTrials.gov Identifier: NCT00270530   History of Changes  
    Other Study ID Numbers: S1954-21/22-2  
    Study First Received: December 23, 2005  
    Last Updated: January 30, 2006  

    Keywords provided by Center for International Health and Development:

    Malaria
    Placental diseases
    Birth complications
    Plasmodium falciparum
    Zambia
    HIV-seropositive
    HIV

    Additional relevant MeSH terms:
    Infection
    Communicable Diseases
    HIV Infections
    Malaria
    Stillbirth
    HIV Seropositivity
    Perinatal Death
    Pyrimethamine
    Sulfadoxine
    Fanasil, pyrimethamine drug combination

    ClinicalTrials.gov processed this data on October 23, 2017
    This information is provided by ClinicalTrials.gov.