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Sponsors and Collaborators: |
Center for International Health and Development Centers for Disease Control and Prevention |
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Information provided by: | Center for International Health and Development |
ClinicalTrials.gov Identifier: | NCT00270530 |
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 |
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Placental Malaria Infection HIV Infections Stillbirth Prematurity Neonatal Deaths |
Drug: Sulfadoxine-pyrimethamine (Fansidar) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia |
Estimated Enrollment: | 454 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | October 2004 |
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:
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:
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Zambia | |
Tropical Diseases Research Centre | |
Ndola, Zambia |
Principal Investigator: | Davidson H Hamer, MD | Center for International Health and Development, Boston University |
Study ID Numbers: | S1954-21/22-2 |
Study First Received: | December 23, 2005 |
Last Updated: | January 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00270530 |
Health Authority: | United States: Federal Government |
Malaria Placental diseases Birth complications Plasmodium falciparum |
Zambia HIV-seropositive HIV |
Pyrimethamine Protozoan Infections Sulfadoxine-pyrimethamine Death Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Malaria Sulfadoxine |
Immunologic Deficiency Syndromes Folic Acid Virus Diseases HIV Infections Sexually Transmitted Diseases Parasitic Diseases Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Coccidiosis Anti-Infective Agents, Urinary |
Enzyme Inhibitors Renal Agents Folic Acid Antagonists Infection Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Lentivirus Infections |