Cotrimoxazol to prevent malaria in HIV-infected pregnant women in Sub-Saharan Africa
| ISRCTN | ISRCTN98835811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98835811 |
| Secondary identifying numbers | 1 |
- Submission date
- 27/08/2012
- Registration date
- 27/09/2012
- Last edited
- 13/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Centre Médical de Bligny
Route de Bligny
Briis-sous-forges
91640
France
| Phone | +33 (0)683 479 439 |
|---|---|
| eklement@altersante.org |
Study information
| Study design | Multicenter open-label non-inferiority randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Togolese National Ethic Committee, January 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2009 |
| Completion date | 31/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 300 |
| Key inclusion criteria | 1. HIV1 2. Women <28 weeks of pregnancy 3. CD4 >200/mm3 4. Hb >7 g/L |
| Key exclusion criteria | 1. Age<15 2. HIV2 or HIV1+2 3. Allergy or ongoing sulfamides treatment |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/08/2012 |
Locations
Countries of recruitment
- France
- Togo
Study participating centre
91640
France
Sponsor information
Research organisation
c/o Dr Elise Klement
Centre Médical de Bligny
Briis-sous-forges
91640
France
| Website | http://www.altersante.org |
|---|---|
"ROR" |
https://ror.org/03sfwdd85 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2014 | Yes | No |
Editorial Notes
13/09/2016: Plain English summary added.
