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Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
This study has been completed.
Sponsor:
Center for International Health and Development
Collaborator:
Centers for Disease Control and Prevention
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
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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 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 |
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 (Adult) |
| Sexes 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
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270530
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
Centers for Disease Control and Prevention
Investigators
| Principal Investigator: | Davidson H Hamer, MD | Center for International Health and Development, Boston University |
More Information
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 |
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 Malaria Stillbirth HIV Seropositivity Perinatal Death Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Protozoan Infections Parasitic Diseases Fetal Death Pregnancy Complications Death Pathologic Processes Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Folic Acid Antagonists Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 23, 2017