NCT00270530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
Last Updated

January 31, 2006

Status Verified

November 1, 2004

First QC Date

December 23, 2005

Last Update Submit

January 30, 2006

Conditions

Placental Malaria InfectionHIV InfectionsStillbirthPrematurityNeonatal Deaths

Keywords

MalariaPlacental diseasesBirth complicationsPlasmodium falciparumZambiaHIV-seropositiveHIV

Outcome Measures

Primary Outcomes (2)

  • • Prevalence of placental malaria infection

  • • Prevalence of maternal peripheral parasitemia

Secondary Outcomes (8)

  • • 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

  • +3 more secondary outcomes

Interventions

Sulfadoxine-pyrimethamine (Fansidar)DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Diseases Research Centre

Ndola, Zambia

Location

Related Publications (2)

  • Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

    PMID: 39324693DERIVED

  • 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.

    PMID: 18008241DERIVED

MeSH Terms

Conditions

HIV InfectionsStillbirthPremature BirthPerinatal DeathMalariaPlacenta DiseasesMalaria, FalciparumHIV Seropositivity

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesFetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsDeathPathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsProtozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Davidson H Hamer, MD

    Center for International Health and Development, Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2005

First Posted

December 28, 2005

Study Start

November 1, 2002

Study Completion

October 1, 2004

Last Updated

January 31, 2006

Record last verified: 2004-11

Locations

ZA(1)