Malaria, FalciparumNCT00126906
Prevention of Malaria During Pregnancy Using Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: Malawi
A study testing Monthly sulfadoxine/pyrimethamine and 2-dose sulfadoxine/pyrimethamine in people with Malaria, Falciparum and HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Malawi.
Trial summary
In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Malaria, Falciparum, HIV Infections
- What is being tested?
- Monthly sulfadoxine/pyrimethamine and 2-dose sulfadoxine/pyrimethamine
- How many people
- 700 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2002to Mar 2005
- Phase
- Interventional
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First or second pregnancy
- Greater than 16 weeks gestation
- Less than 28 weeks gestation
- Consent for HIV testing
Who cannot join
- Less than 15 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly - Malawi
In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. In this investigation, this two dose strategy was compared to a monthly SP regimen. The objective for the study was to determine the efficacy of the different regimens for HIV positive and HIV negative women in the prevention of placental malaria.
Read the detailed description
In this protocol the researchers wish to elaborate prior investigations on factors which may affect prevalence and malarial parasite density in pregnant women in Malawi. Primarily, this investigation will evaluate the efficacy of the current Malawian national policy, sulfadoxine-pyrimethamine (SP) 2-dose intermittent protective treatment (IPT) strategy, and compare it to a monthly SP strategy for use in preventing malaria during pregnancy. Previous investigations in Malawi have demonstrated that: prevention of malaria during pregnancy is most important during the first and second pregnancies, particularly during the rainy season when malaria transmission is highest; and an efficacious antimalarial regimen which clears parasitemia and placental infection will result in a reduction in the incidence of low birth weight, the single greatest risk factor for neonatal and early infant mortality. There appears to be an interaction between HIV infection and placental malaria, with HIV-positive pregnant women having higher prevalences and densities of peripheral and placental parasitemia compared with HIV-negative pregnant women. This finding requires closer examination, in light of the high prevalence and incidence of HIV infection in Malawi and other African countries. Previously in Malawi, a 2-dose IPT regimen of SP administered during the second and third trimester of pregnancy was effective at clearing placental malaria infection at delivery More recent studies in both Malawi and Kenya show that 2 doses may not be adequate in clearing placental parasitemia especially in women who are HIV infected. In the Kenya study, HIV-positive women required 3 doses of SP (that were delivered in a monthly dosing scheme) to achieve similar reductions in placental parasitemia that were seen in HIV-negative women at 2 doses. There remains a need to identify the optimal dosing schedule for an intermittent treatment regimen; the Kenya findings need to be confirmed before decisions are made on national and global levels. This is especially important given the possibility of increasing SP resistance in Malawi. The question of HIV infection and its role in malaria during pregnancy, both in terms of impact on regimen effectiveness and on the incidence of adverse sulfa reactions needs to be examined. This study proposes to determine the efficacy of the current regimen of 2-dose SP intermittent protective treatment (IPT) and to compare it to monthly SP dosing in clearing placental parasitemia at delivery in Machinga district in Malawi where there is a high level of malaria transmission and an HIV seropositivity rate of nearly 20% in reproductive age woman. This study will also explore the effect of HIV seropositivity on the safety and efficacy of intermittent preventive treatment during pregnancy.
- Conditions
- Malaria, Falciparum, HIV Infections
- Being tested
- Monthly sulfadoxine/pyrimethamine, 2-dose sulfadoxine/pyrimethamine
- Keywords
- Malaria, Pregnancy, HIV
- Medical subject headings
- Malaria, Falciparum, HIV Infections, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly sulfadoxine/pyrimethamineDrug
2-dose sulfadoxine/pyrimethamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
Secondary outcomes (3)
Proportion of newborns with low birth weight, stratified by HIV status
Proportion of women with third trimester anemia, stratified by HIV status
Proportion of pregnancies that suffer fetal loss, stratified by HIV status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startOct 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies 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 N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ministry of Health, Malawi
- Investigators
- Scott J Filler, MD, DTM&H, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126906
- Sponsor's protocol ID
- CDC-NCID-3429
- Status last verified
- Aug 2005
- First submitted
- 3 Aug 2005
- Last updated
- 23 Aug 2005
- Results posted
- No
Publications
Parise ME, Ayisi JG, Nahlen BL, Schultz LJ, Roberts JM, Misore A, Muga R, Oloo AJ, Steketee RW. Efficacy of sulfadoxine-pyrimethamine for prevention of placental malaria in an area of Kenya with a high prevalence of malaria and human immunodeficiency virus infection. Am J Trop Med Hyg. 1998 Nov;59(5):813-22. doi: 10.4269/ajtmh.1998.59.813.
PubMed 9840604Pons-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 39324693Filler SJ, Kazembe P, Thigpen M, Macheso A, Parise ME, Newman RD, Steketee RW, Hamel M. Randomized trial of 2-dose versus monthly sulfadoxine-pyrimethamine intermittent preventive treatment for malaria in HIV-positive and HIV-negative pregnant women in Malawi. J Infect Dis. 2006 Aug 1;194(3):286-93. doi: 10.1086/505080. Epub 2006 Jun 20.
PubMed 16826475
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly - Malawi
- ClinicalTrials.gov ID
- NCT00126906
- Acronym / sponsor ID
- CDC-NCID-3429
- Conditions
- Malaria, Falciparum, HIV Infections
- Keywords
- Malaria, Pregnancy, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ministry of Health, Malawi
- Study start
- Oct 2002
- Study completion
- Mar 2005
- First posted
- 5 Aug 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.
In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. In this investigation, this two dose strategy was compared to a monthly SP regimen. The objective for the study was to determine the efficacy of the different regimens for HIV positive and HIV negative women in the prevention of placental malaria.
Detailed description
In this protocol the researchers wish to elaborate prior investigations on factors which may affect prevalence and malarial parasite density in pregnant women in Malawi. Primarily, this investigation will evaluate the efficacy of the current Malawian national policy, sulfadoxine-pyrimethamine (SP) 2-dose intermittent protective treatment (IPT) strategy, and compare it to a monthly SP strategy for use in preventing malaria during pregnancy. Previous investigations in Malawi have demonstrated that: prevention of malaria during pregnancy is most important during the first and second pregnancies, particularly during the rainy season when malaria transmission is highest; and an efficacious antimalarial regimen which clears parasitemia and placental infection will result in a reduction in the incidence of low birth weight, the single greatest risk factor for neonatal and early infant mortality. There appears to be an interaction between HIV infection and placental malaria, with HIV-positive pregnant women having higher prevalences and densities of peripheral and placental parasitemia compared with HIV-negative pregnant women. This finding requires closer examination, in light of the high prevalence and incidence of HIV infection in Malawi and other African countries. Previously in Malawi, a 2-dose IPT regimen of SP administered during the second and third trimester of pregnancy was effective at clearing placental malaria infection at delivery More recent studies in both Malawi and Kenya show that 2 doses may not be adequate in clearing placental parasitemia especially in women who are HIV infected. In the Kenya study, HIV-positive women required 3 doses of SP (that were delivered in a monthly dosing scheme) to achieve similar reductions in placental parasitemia that were seen in HIV-negative women at 2 doses. There remains a need to identify the optimal dosing schedule for an intermittent treatment regimen; the Kenya findings need to be confirmed before decisions are made on national and global levels. This is especially important given the possibility of increasing SP resistance in Malawi. The question of HIV infection and its role in malaria during pregnancy, both in terms of impact on regimen effectiveness and on the incidence of adverse sulfa reactions needs to be examined. This study proposes to determine the efficacy of the current regimen of 2-dose SP intermittent protective treatment (IPT) and to compare it to monthly SP dosing in clearing placental parasitemia at delivery in Machinga district in Malawi where there is a high level of malaria transmission and an HIV seropositivity rate of nearly 20% in reproductive age woman. This study will also explore the effect of HIV seropositivity on the safety and efficacy of intermittent preventive treatment during pregnancy.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- First or second pregnancy
- Greater than 16 weeks gestation
- Less than 28 weeks gestation
- Consent for HIV testing
Key exclusion criteria (1 listed)
- Less than 15 years old
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 |
|---|---|---|
| Monthly sulfadoxine/pyrimethamine | Drug | – |
| 2-dose sulfadoxine/pyrimethamine | Drug | – |
Primary outcome
Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
3 secondary outcomes
Proportion of newborns with low birth weight, stratified by HIV status
Proportion of women with third trimester anemia, stratified by HIV status
Proportion of pregnancies that suffer fetal loss, stratified by HIV status
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 23 Aug 2005.
- Background: PubMed 9840604Parise ME, Ayisi JG, Nahlen BL, Schultz LJ, Roberts JM, Misore A, Muga R, Oloo AJ, Steketee RW. Efficacy of sulfadoxine-pyrimethamine for prevention of placental malaria in an area of Kenya with a high prevalence of malaria and human immunodeficiency virus infection. Am J Trop Med Hyg. 1998 Nov;59(5):813-22. doi: 10.4269/ajtmh.1998.59.813.
- 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 16826475Filler SJ, Kazembe P, Thigpen M, Macheso A, Parise ME, Newman RD, Steketee RW, Hamel M. Randomized trial of 2-dose versus monthly sulfadoxine-pyrimethamine intermittent preventive treatment for malaria in HIV-positive and HIV-negative pregnant women in Malawi. J Infect Dis. 2006 Aug 1;194(3):286-93. doi: 10.1086/505080. Epub 2006 Jun 20.
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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.
Scott J Filler, MD, DTM&H principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly sulfadoxine/pyrimethamine and 2-dose sulfadoxine/pyrimethamine in people with Malaria, Falciparum and HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Malawi.
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 4 inclusion and 1 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 23 Aug 2005. 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 Malawi. 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.
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?
Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status. 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 NCT00126906, which also lists 3 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 23 Aug 2005.