Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270530
Status:
COMPLETED
Last Update Posted:
2006-01-31
First Post:
2005-12-23
Brief Title:
Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
Sponsor:
Center for International Health and Development
Organization:
Center for International Health and Development
Study Overview
Official Title:
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia
Status:
COMPLETED
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None