Placental Malaria InfectionPhase 4NCT00270530
Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
A Phase 4 study testing Sulfadoxine-pyrimethamine (Fansidar) in people with Placental Malaria Infection and HIV Infections, run by Center for International Health and Development at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Placental Malaria Infection, HIV Infections, Stillbirth
- What is being tested?
- Sulfadoxine-pyrimethamine (Fansidar)
- How many people
- 454 participants
- Where
- 1 siteZambia
- Study dates
- Nov 2002to Oct 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative 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.
Read the 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
- Being tested
- Sulfadoxine-pyrimethamine (Fansidar)
- Keywords
- Malaria, Placental diseases, Birth complications, Plasmodium falciparum, Zambia, HIV-seropositive, HIV
- Medical subject headings
- HIV Infections, Stillbirth, Premature Birth, Perinatal Death, Malaria, Placenta Diseases, Malaria, Falciparum, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine-pyrimethamine (Fansidar)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
• Third trimester anemia
• Third trimester severe anemia
• Proportion of mothers who develop symptomatic malaria during the course of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startNov 2002
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Placental Malaria InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 454 participants
Sponsor and investigators
- Lead sponsor
- Center for International Health and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Davidson H Hamer, MD, Principal investigator, Center for International Health and Development, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270530
- Sponsor's protocol ID
- S1954-21/22-2
- Status last verified
- Nov 2004
- First submitted
- 23 Dec 2005
- Last updated
- 31 Jan 2006
- Results posted
- No
Publications
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.
PubMed 39324693Hamer 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.
PubMed 18008241
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia
- ClinicalTrials.gov ID
- NCT00270530
- Acronym / sponsor ID
- S1954-21/22-2
- Keywords
- Malaria, Placental diseases, Birth complications, Plasmodium falciparum, Zambia, HIV-seropositive, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants
- Lead sponsor
- Center for International Health and DevelopmentUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2002
- Study completion
- Oct 2004
- First posted
- 28 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfadoxine-pyrimethamine (Fansidar) | Drug | – |
Primary outcome
• Prevalence of placental malaria infection
• Prevalence of maternal peripheral parasitemia
8 secondary outcomes
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2006.
- Derived from this study: PubMed 39324693Pons-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.
- Derived from this study: PubMed 18008241Hamer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davidson H Hamer, MD principal investigator
Center for International Health and Development, Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfadoxine-pyrimethamine (Fansidar) in people with Placental Malaria Infection and HIV Infections, run by Center for International Health and Development at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Prevalence of placental malaria infection. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00270530, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2006.