Back to resultsIntermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
Primary Purpose
Placental Malaria Infection, HIV Infections, Stillbirth
Status
Completed
Phase
Phase 4
Locations
Zambia
Study Type
Interventional
Intervention
Sulfadoxine-pyrimethamine (Fansidar)
Sponsored by
About this trial
This is an interventional treatment trial for Placental Malaria Infection focused on measuring Malaria, Placental diseases, Birth complications, Plasmodium falciparum, Zambia, HIV-seropositive, HIV
Eligibility 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
Sites / Locations
- Tropical Diseases Research Centre
Outcomes
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
Full Information
NCT ID
NCT00270530
First Posted
December 23, 2005
Last Updated
January 30, 2006
Sponsor
Center for International Health and Development
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00270530
Brief Title
Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
Official Title
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Center for International Health and Development
Collaborators
Centers for Disease Control and Prevention
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placental Malaria Infection, HIV Infections, Stillbirth, Prematurity, Neonatal Deaths
Keywords
Malaria, Placental diseases, Birth complications, Plasmodium falciparum, Zambia, HIV-seropositive, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
454 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine-pyrimethamine (Fansidar)
Primary Outcome Measure Information:
Title
• Prevalence of placental malaria infection
Title
• Prevalence of maternal peripheral parasitemia
Secondary Outcome Measure Information:
Title
• Prevalence of maternal peripheral parasitemia
Title
• Birth weight, including the proportion of LBW infants
Title
• Incidence of prematurity
Title
• Neonatal and fetal death and third trimester stillbirth
Title
• Incidence of neonatal jaundice
Title
• Third trimester anemia
Title
• Third trimester severe anemia
Title
• Proportion of mothers who develop symptomatic malaria during the course of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davidson H Hamer, MD
Organizational Affiliation
Center for International Health and Development, Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tropical Diseases Research Centre
City
Ndola
Country
Zambia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18008241
Citation
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.
Results Reference
derived
Learn more about this trial
Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
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