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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

December 23, 2005
January 30, 2006
November 2002
Not Provided
  • • Prevalence of placental malaria infection
  • • Prevalence of maternal peripheral parasitemia
Same as current
Complete list of historical versions of study NCT00270530 on ClinicalTrials.gov Archive Site
  • • 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
Same as current
Not Provided
Not Provided
 
Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Placental Malaria Infection
  • HIV Infections
  • Stillbirth
  • Prematurity
  • Neonatal Deaths
Drug: Sulfadoxine-pyrimethamine (Fansidar)
Not Provided
Hamer DH, Mwanakasale V, Macleod WB, Chalwe V, Mukwamataba D, Champo D, Mwananyanda L, Chilengi R, Mubikayi L, Mulele CK, Mulenga M, Thea DM, Gill CJ. Two-dose versus monthly intermittent preventive treatment of malaria with sulfadoxine-pyrimethamine in HIV-seropositive pregnant Zambian women. J Infect Dis. 2007 Dec 1;196(11):1585-94. Epub 2007 Oct 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
454
October 2004
Not Provided

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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT00270530
S1954-21/22-2
Not Provided
Not Provided
Center for International Health and Development
Centers for Disease Control and Prevention
Principal Investigator: Davidson H Hamer, MD Center for International Health and Development, Boston University
Center for International Health and Development
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP