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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN98835811 |
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Date of registration:
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27/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cotrimoxazol to prevent malaria in HIV-infected pregnant women in Sub-Saharan Africa
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Scientific title:
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Effectiveness of Trimethoprim-Sulfamethoxazole to prevent malaria in HIV-infected pregnant women in P. falciparum-endemic Sub-Saharan Africa: a randomized controlled trial |
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Date of first enrolment:
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01/01/2009 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN98835811 |
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Study type:
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Interventional |
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Study design:
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Multicenter open-label non-inferiority randomized study (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Togo
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Elise
Klement |
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Address:
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Centre Médical de Bligny
Route de Bligny
91640
Briis-sous-forges
France |
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Telephone:
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+33 (0)683 479 439 |
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Email:
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eklement@altersante.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. HIV1
2. Women <28 weeks of pregnancy
3. CD4 >200/mm3
4. Hb >7 g/L
Exclusion criteria: 1. Age<15
2. HIV2 or HIV1+2
3. Allergy or ongoing sulfamides treatment
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Malaria HIV vertical transmission
Infections and Infestations
Plasmodium falciparum malaria
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Intervention(s)
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Women who volunteered were randomized to receive either daily 80/400mg trimethoprim-sulfamethoxazole (CMX) or intermittent preventive treatment (IPT) with 1000/50mg sulfadoxine-pyrimethamine (SP) as follows: first dose at inclusion day, then 1 dose per month until delivery. Women were followed monthly clinically and biologically (Hb and blood smear) free of charge, and were asked to deliver in the study center. At delivery a placenta sample was collected. Babies were followed until the age of 3 months.
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Primary Outcome(s)
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Incidence of malaria during pregnancy, calculated as the number of malaria events per person year.
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Secondary Outcome(s)
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1. Blood parasitaemia in women and new-born
2. Treatment tolerance
3. Pregnancy outcome
4. Birth weight
5. Placental malarial infection
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Source(s) of Monetary Support
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AlterSanté (France)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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