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

Purpose

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.

Condition	Intervention	Phase
Placental Malaria Infection HIV Infections Stillbirth Prematurity Neonatal Deaths	Drug: Sulfadoxine-pyrimethamine (Fansidar)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Malaria Stillbirth

Drug Information available for: Pyrimethamine

Genetic and Rare Diseases Information Center resources: Malaria Placenta Disorder

U.S. FDA Resources

Further study details as provided by Center for International Health and Development:

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


Estimated Enrollment:	454
Study Start Date:	November 2002
Estimated Study Completion Date:	October 2004

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


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270530

Locations


Zambia
Tropical Diseases Research Centre
Ndola, Zambia

Sponsors and Collaborators

Center for International Health and Development

Centers for Disease Control and Prevention

Investigators


Principal Investigator:	Davidson H Hamer, MD	Center for International Health and Development, Boston University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2007 Oct 25.


ClinicalTrials.gov Identifier:	NCT00270530 History of Changes
Other Study ID Numbers:	S1954-21/22-2
Study First Received:	December 23, 2005
Last Updated:	January 30, 2006
Health Authority:	United States: Federal Government

Keywords provided by Center for International Health and Development:


Malaria Placental diseases Birth complications Plasmodium falciparum	Zambia HIV-seropositive HIV

Additional relevant MeSH terms:


Infection Communicable Diseases HIV Infections Malaria Stillbirth HIV Seropositivity Perinatal Death Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Protozoan Infections Parasitic Diseases Fetal Death Pregnancy Complications Death Pathologic Processes Pyrimethamine Sulfadoxine Fanasil, pyrimethamine drug combination Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Folic Acid Antagonists Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016