Effectiveness of two antifolate prophylactic strategies against malaria in HIV-positive pregnant women in Bangui, Central African Republic: study protocol for a randomized controlled trial (MACOMBA).
BACKGROUND
Co-infection with malaria parasite and HIV is an emerging public health problem in tropical areas, particularly in pregnant women, and management of the concurrent effects of these two infections is challenging. Co-trimoxazole is a sulfamide preparation used to prevent opportunistic infections in HIV-infected patients, and many studies have reported that it has significant activity against malaria. As the efficacy of intermittent preventive treatment (IPT) with sulfadoxine-pyrimethamine (SP) against malaria is decreasing, co-trimoxazole might be an alternative for preventing malaria among HIV-infected populations. The aim of this study is to compare the effectiveness of SP-IPT, which is recommended for the prevention of malaria during pregnancy in the Central African Republic, with that of a daily dose of co-trimoxazole against P. falciparum infections among HIV-infected pregnant women in Bangui, the capital of the Central African Republic.


METHODS
The MACOMBA study (MAternity and COntrol of Malaria-HIV co-infection in BAngui) is a multicentre open-label randomized clinical trial conducted at four maternity hospitals in Bangui. All HIV-infected pregnant women presenting for an antenatal clinic visit between the weeks 16 and 28 of amenorrhoea, with a CD4 count of more than 350 cells/mm3, will be eligible. All the women will provide written consent before being enrolled in the study and will then be randomly allocated to either SP-IPT (25 mg of sulfadoxine and 1.25 mg of pyrimethamine) or daily co-trimoxazole doses (960 mg per dose). The primary end-point is the placental malaria parasitaemia rate at delivery. Other main outcome measures include the number of malaria episodes during pregnancy, safety, and treatment compliance. Furthermore, the frequency of molecular resistance markers dhfr and dhps will be measured.


CONCLUSIONS
In this trial, we seek to confirm whether co-trimoxazole is operationally suitable to replace SP-IPT in order to prevent malaria among pregnant women infected with HIV in the Central African Republic.


BACKGROUND
ClinicalTrials.gov Identifier: NCT01746199.
Institut Pasteur of Bangui, International Network of Instituts Pasteur, PO Box 923, Pasteur Avenue, Bangui, Central African Republic. amanirak@yahoo.fr
Alexandre
A
Manirakiza
Abdoulaye
A
Sepou
Eugène
E
Serdouma
Samuel
S
Gondje
Ghislain Géraud Banthas
GG
Bata
Sandrine
S
Moussa
Aude
A
Boulay
Jean Methode
JM
Moyen
Olga
O
Sakanga
Lenaig
L
Le-Fouler
Mirdad
M
Kazanji
Muriel
M
Vray
D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects; D002488:Central African Republic; D002985:Clinical Protocols; D060085:Coinfection; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005493:Folic Acid Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D015658:HIV Infections / Q000150:complications* / Q000175:diagnosis; D006771:Hospitals, Maternity; D006801:Humans; D016778:Malaria, Falciparum / Q000150:complications / Q000175:diagnosis / Q000517:prevention & control*; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000175:diagnosis / Q000517:prevention & control*; D011295:Prenatal Care; D011739:Pyrimethamine / Q000008:administration & dosage* / Q000009:adverse effects; D012107:Research Design; D013413:Sulfadoxine / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects
D000962:Antimalarials; D004338:Drug Combinations; D005493:Folic Acid Antagonists; C001205:fanasil, pyrimethamine drug combination; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D013413:Sulfadoxine; D011739:Pyrimethamine