Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
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ClinicalTrials.gov Identifier: NCT00270530 |
Recruitment Status :
Completed
First Posted : December 28, 2005
Last Update Posted : January 31, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Placental Malaria Infection HIV Infections Stillbirth Prematurity Neonatal Deaths | Drug: Sulfadoxine-pyrimethamine (Fansidar) | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 454 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia |
Study Start Date : | November 2002 |
Study Completion Date : | October 2004 |

- • Prevalence of placental malaria infection
- • Prevalence of maternal peripheral parasitemia
- • 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270530
Zambia | |
Tropical Diseases Research Centre | |
Ndola, Zambia |
Principal Investigator: | Davidson H Hamer, MD | Center for International Health and Development, Boston University |
ClinicalTrials.gov Identifier: | NCT00270530 |
Other Study ID Numbers: |
S1954-21/22-2 |
First Posted: | December 28, 2005 Key Record Dates |
Last Update Posted: | January 31, 2006 |
Last Verified: | November 2004 |
Malaria Placental diseases Birth complications Plasmodium falciparum |
Zambia HIV-seropositive HIV |
Infections Communicable Diseases Malaria HIV Seropositivity Stillbirth Perinatal Death Disease Attributes Pathologic Processes HIV Infections Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Protozoan Infections Parasitic Diseases Vector Borne Diseases Pregnancy Complications Fetal Death Death Pyrimethamine Sulfadoxine Fanasil, pyrimethamine drug combination Antimalarials Antiprotozoal Agents Antiparasitic Agents |