Clinical trial NCT00270530: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Placental Malaria Infection
HIV Infections
Stillbirth
Prematurity
Neonatal Deaths
Keywords: Malaria
Placental diseases
Birth complications
Plasmodium falciparum
Zambia
HIV-seropositive
HIV
Lead sponsor: Center for International Health and Development
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2005-12-28
Enrollment: 454
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: • Prevalence of placental malaria infection
measure: • Prevalence of maternal peripheral parasitemia
Secondary outcomes:
measure: • Prevalence of maternal peripheral parasitemia
measure: • Birth weight, including the proportion of LBW infants
measure: • Incidence of prematurity
measure: • Neonatal and fetal death and third trimester stillbirth
measure: • Incidence of neonatal jaundice
measure: • Third trimester anemia
measure: • Third trimester severe anemia
measure: • Proportion of mothers who develop symptomatic malaria during the course of pregnancy
Other outcomes:
Locations:
city: Ndola
country: Zambia
facility: Tropical Diseases Research Centre
Study officials:
affiliation: Center for International Health and Development, Boston University
name: Davidson H Hamer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.