Skip to main content
OpenTrials
Completed

NCT Number: NCT00270530

Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Placental Malaria Infection Blood-Borne Infections Communicable Diseases Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Neonatal Deaths Obstetric Labor Complications Obstetric Labor, Premature Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Placenta Diseases Pregnancy Complications Premature Birth Prematurity Protozoan Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Stillbirth Urogenital Diseases Vector Borne Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tropical Diseases Research Centre

Ndola, Zambia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfadoxine-pyrimethamine (Fansidar)

Drug

Primary outcomes

  1. • Prevalence of placental malaria infection

  2. • Prevalence of maternal peripheral parasitemia

Secondary outcomes

  1. • Prevalence of maternal peripheral parasitemia

  2. • Birth weight, including the proportion of LBW infants

  3. • Incidence of prematurity

  4. • Neonatal and fetal death and third trimester stillbirth

  5. • Incidence of neonatal jaundice

  6. • Third trimester anemia

  7. • Third trimester severe anemia

  8. • Proportion of mothers who develop symptomatic malaria during the course of pregnancy

Sponsors and collaborators

Lead sponsor

Center for International Health and Development

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia

Important dates

Study start
2002
Study completion
2004
First posted
Dec 28, 2005
Registry last updated
Jan 31, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.