NCT00270530|CompletedPhase 4
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Sponsor study identifier
interventional
454
1 country
1
Study Start
November 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2002
Date type not reportedThis date has not been verified as actual or estimated.
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
December 23, 2005
Actual (reported)December 28, 2005
Actual (reported)• Prevalence of placental malaria infection
• Prevalence of maternal peripheral parasitemia
• 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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Tropical Diseases Research Centre
Ndola, Zambia
Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.
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. doi: 10.1086/522142. Epub 2007 Oct 25.
Davidson H Hamer, MD
Center for International Health and Development, Boston University
First Submitted
December 23, 2005
First Posted
December 28, 2005
Study Start
November 2002
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
October 2004
Date type not reportedSafety Study of Once a Day ART and Opiate Substitute.
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This date has not been verified as actual or estimated.
Last Updated
January 31, 2006
Record last verified: 2004-11
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Source: ClinicalTrials.gov.
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