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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Malawi Ministry of Health and Population |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00126906 |
In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. In this investigation, this two dose strategy was compared to a monthly SP regimen. The objective for the study was to determine the efficacy of the different regimens for HIV positive and HIV negative women in the prevention of placental malaria.
Condition | Intervention |
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Malaria, Falciparum HIV Infections |
Drug: Monthly sulfadoxine/pyrimethamine Drug: 2-dose sulfadoxine/pyrimethamine |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly – Malawi |
Estimated Enrollment: | 700 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | March 2005 |
In this protocol the researchers wish to elaborate prior investigations on factors which may affect prevalence and malarial parasite density in pregnant women in Malawi. Primarily, this investigation will evaluate the efficacy of the current Malawian national policy, sulfadoxine-pyrimethamine (SP) 2-dose intermittent protective treatment (IPT) strategy, and compare it to a monthly SP strategy for use in preventing malaria during pregnancy. Previous investigations in Malawi have demonstrated that: prevention of malaria during pregnancy is most important during the first and second pregnancies, particularly during the rainy season when malaria transmission is highest; and an efficacious antimalarial regimen which clears parasitemia and placental infection will result in a reduction in the incidence of low birth weight, the single greatest risk factor for neonatal and early infant mortality. There appears to be an interaction between HIV infection and placental malaria, with HIV-positive pregnant women having higher prevalences and densities of peripheral and placental parasitemia compared with HIV-negative pregnant women. This finding requires closer examination, in light of the high prevalence and incidence of HIV infection in Malawi and other African countries. Previously in Malawi, a 2-dose IPT regimen of SP administered during the second and third trimester of pregnancy was effective at clearing placental malaria infection at delivery More recent studies in both Malawi and Kenya show that 2 doses may not be adequate in clearing placental parasitemia especially in women who are HIV infected. In the Kenya study, HIV-positive women required 3 doses of SP (that were delivered in a monthly dosing scheme) to achieve similar reductions in placental parasitemia that were seen in HIV-negative women at 2 doses. There remains a need to identify the optimal dosing schedule for an intermittent treatment regimen; the Kenya findings need to be confirmed before decisions are made on national and global levels. This is especially important given the possibility of increasing SP resistance in Malawi. The question of HIV infection and its role in malaria during pregnancy, both in terms of impact on regimen effectiveness and on the incidence of adverse sulfa reactions needs to be examined. This study proposes to determine the efficacy of the current regimen of 2-dose SP intermittent protective treatment (IPT) and to compare it to monthly SP dosing in clearing placental parasitemia at delivery in Machinga district in Malawi where there is a high level of malaria transmission and an HIV seropositivity rate of nearly 20% in reproductive age woman. This study will also explore the effect of HIV seropositivity on the safety and efficacy of intermittent preventive treatment during pregnancy.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Malawi | |
Machinga District Hospital | |
Liwonde, Malawi |
Principal Investigator: | Scott J Filler, MD, DTM&H | Centers for Disease Control and Prevention |
Study ID Numbers: | CDC-NCID-3429 |
Study First Received: | August 3, 2005 |
Last Updated: | August 22, 2005 |
ClinicalTrials.gov Identifier: | NCT00126906 |
Health Authority: | United States: Federal Government |
Malaria Pregnancy HIV |
Pyrimethamine Protozoan Infections Sulfadoxine-pyrimethamine Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Malaria Sulfadoxine Immunologic Deficiency Syndromes |
Malaria, Falciparum Folic Acid Virus Diseases HIV Seropositivity HIV Infections Sexually Transmitted Diseases Parasitic Diseases Retroviridae Infections |
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 Infection Folic Acid Antagonists Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Lentivirus Infections |