Plain English Summary
Background and study aims
Malaria is a tropical disease spread by mosquitoes. It affects up to 500 million people each year, killing 1-3 million, mostly pregnant women and children in sub-Saharan Africa. The HIV pandemic disproportionately affects sexually active women in Africa, who as a result are more vulnerable to malaria. Infection with both malaria and HIV during pregnancy leads to anaemia (decreased red blood cells), low birth weight, and increased risk of death. The WHO recommends intermittent preventive treatment (IPT) with the drugs sulphadoxine-pyrimethamine (SP) during pregnancy in areas with a high HIV prevalence. On the other hand, UNAIDS/UNICEF recommend daily treatment with the drugs trimethoprim-sulfamethoxazole (cotrimoxazole: CMX) for all HIV-positive pregnant women. Unfortunately, taking CMX and IPT with SP can cause dangerous side effects for pregnant women and infants, the risk of side-effects being higher in HIV-positive patients. CMX has been proven to protect children and HIV-positive adults against malaria, and CMX alone may be effective at preventing malaria during pregnancy. The aim of this study is to compare the effects of CMX with standard IPT on malaria risk in HIV-pregnant women in rural sub-Saharan Africa.
Who can participate?
HIV-positive pregnant women aged 15 to 45
What does the study involve?
Women are randomly allocated to be treated with either daily CMX or IPT with SP one dose per month until delivery. Women are followed up monthly and are asked to deliver in the study center. At delivery a sample of the placenta is collected. Babies are followed up until the age of 3 months. The number of malaria cases, pregnancy outcome and birth weights are measured in both groups.
What are the possible benefits and risks of participating?
All treatments and tests are free of charge. All pregnant women receive a mosquito net treated with insecticide. Treatment to prevent mother-to-child transmission of HIV follows the national and WHO guidelines. The main side effects of the study drugs are anaemia and skin allergy.
Where is the study run from?
Nineteen health centers participated in the study: CMS Noepe, Hôpital Assahoun, Hôpital Agou-Gare, Hôpital Agou Bethesda, CMS Kpogandji, CMS Kpadapé, CHP Kpalimé, Polyclinique Kpalimé, CMS Adéta, CMS Goudévé, Hôpital Danyi, Hôpital Notsè, Hôpital Anié, CMS Glei, CMS Agbonou, Polyclinique Atakpamé, Hôpital Atakpamé, CMS Akparè, CMS Témédja.
When is the study starting and how long is it expected to run for?
January 2009 to August 2012
Who is funding the study?
AlterSanté (France)
Who is the main contact?
Dr Elise Klement
eklement@altersante.org
Trial website
Contact information
Type
Scientific
Primary contact
Dr Elise Klement
ORCID ID
Contact details
Centre Médical de Bligny
Route de Bligny
Briis-sous-forges
91640
France
+33 (0)683 479 439
eklement@altersante.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Effectiveness of Trimethoprim-Sulfamethoxazole to prevent malaria in HIV-infected pregnant women in P. falciparum-endemic Sub-Saharan Africa: a randomized controlled trial
Acronym
Study hypothesis
Cotrimoxazol is non inferior to standard intermittent preventive treatment (IPT) on malaria risk in Human immunodeficiency virus (HIV) pregnant women in rural sub-Saharan Africa.
Ethics approval
Togolese National Ethic Committee, January 2009
Study design
Multicenter open-label non-inferiority randomized study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Malaria HIV vertical transmission
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Trimethoprim-sulfamethoxazole, sulfadoxine-pyrimethamine
Primary outcome measure
Incidence of malaria during pregnancy, calculated as the number of malaria events per person year.
Secondary outcome measures
1. Blood parasitaemia in women and new-born
2. Treatment tolerance
3. Pregnancy outcome
4. Birth weight
5. Placental malarial infection
Overall trial start date
01/01/2009
Overall trial end date
31/08/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. HIV1
2. Women <28 weeks of pregnancy
3. CD4 >200/mm3
4. Hb >7 g/L
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300
Participant exclusion criteria
1. Age<15
2. HIV2 or HIV1+2
3. Allergy or ongoing sulfamides treatment
Recruitment start date
01/01/2009
Recruitment end date
31/08/2012
Locations
Countries of recruitment
Togo
Trial participating centre
Centre Médical de Bligny
Briis-sous-forges
91640
France
Sponsor information
Organisation
AlterSanté (France)
Sponsor details
c/o Dr Elise Klement
Centre Médical de Bligny
Briis-sous-forges
91640
France
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
AlterSanté (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24336820