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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 infe...

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Autores principales: Manirakiza, Alexandre, Sepou, Abdoulaye, Serdouma, Eugène, Gondje, Samuel, Bata, Ghislain Géraud Banthas, Moussa, Sandrine, Boulay, Aude, Moyen, Jean Methode, Sakanga, Olga, Le-Fouler, Lenaig, Kazanji, Mirdad, Vray, Muriel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3751878/
https://www.ncbi.nlm.nih.gov/pubmed/23945130
http://dx.doi.org/10.1186/1745-6215-14-255
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author Manirakiza, Alexandre
Sepou, Abdoulaye
Serdouma, Eugène
Gondje, Samuel
Bata, Ghislain Géraud Banthas
Moussa, Sandrine
Boulay, Aude
Moyen, Jean Methode
Sakanga, Olga
Le-Fouler, Lenaig
Kazanji, Mirdad
Vray, Muriel
author_facet Manirakiza, Alexandre
Sepou, Abdoulaye
Serdouma, Eugène
Gondje, Samuel
Bata, Ghislain Géraud Banthas
Moussa, Sandrine
Boulay, Aude
Moyen, Jean Methode
Sakanga, Olga
Le-Fouler, Lenaig
Kazanji, Mirdad
Vray, Muriel
author_sort Manirakiza, Alexandre
collection PubMed
description 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/DESIGN: 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/mm(3), 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01746199.
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spelling pubmed-37518782013-08-24 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) Manirakiza, Alexandre Sepou, Abdoulaye Serdouma, Eugène Gondje, Samuel Bata, Ghislain Géraud Banthas Moussa, Sandrine Boulay, Aude Moyen, Jean Methode Sakanga, Olga Le-Fouler, Lenaig Kazanji, Mirdad Vray, Muriel Trials Study Protocol 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/DESIGN: 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/mm(3), 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01746199. BioMed Central 2013-08-14 /pmc/articles/PMC3751878/ /pubmed/23945130 http://dx.doi.org/10.1186/1745-6215-14-255 Text en Copyright © 2013 Manirakiza et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Manirakiza, Alexandre
Sepou, Abdoulaye
Serdouma, Eugène
Gondje, Samuel
Bata, Ghislain Géraud Banthas
Moussa, Sandrine
Boulay, Aude
Moyen, Jean Methode
Sakanga, Olga
Le-Fouler, Lenaig
Kazanji, Mirdad
Vray, Muriel
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3751878/
https://www.ncbi.nlm.nih.gov/pubmed/23945130
http://dx.doi.org/10.1186/1745-6215-14-255
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