Condition category
Infections and Infestations
Date applied
27/08/2012
Date assigned
27/09/2012
Last edited
13/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.altersante.org

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24336820

Publication citations

Additional files

Editorial Notes

13/09/2016: Plain English summary added.