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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Center for International Health and Development
ClinicalTrials.gov Identifier:
NCT00270530
First received: December 23, 2005
Last updated: January 30, 2006
Last verified: November 2004
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia

Resource links provided by NLM:


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

Estimated Enrollment: 454
Study Start Date: November 2002
Estimated 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
  • Proportion of mothers who develop symptomatic malaria during the course of pregnancy
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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
Investigators
Principal Investigator: Davidson H Hamer, MD Center for International Health and Development, Boston University
  More Information

No publications provided by Center for International Health and Development

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Health Authority: United States: Federal Government

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
Acquired Immunodeficiency Syndrome
Malaria
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary

ClinicalTrials.gov processed this record on October 19, 2014