Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Infected Women Receiving Cotrimoxazole Prophylaxis: A Multicenter Randomized Placebo-Controlled Trial

PLoS Medicine

Volumn 11, Issue 9, 2014, Pages

  González, Raquel ^a,b   Desai, Meghna ^c   Macete, Eusebio ^b   Ouma, Peter ^c,d   Kakolwa, Mwaka A ^e   Abdulla, Salim ^e   Aponte, John J ^a,b   Bulo, Helder ^b   Kabanywanyi, Abdunoor M ^e   Katana, Abraham ^c,d   Maculuve, Sonia ^b   Mayor, Alfredo ^a,b   Nhacolo, Arsenio ^b   Otieno, Kephas ^c,d   Pahlavan, Golbahar ^a   Rupérez, María ^a,b   Sevene, Esperança ^b   Slutsker, Laurence ^c   Vala, Anifa ^b   Williamsom, John ^c   Menéndez, Clara ^a,b   more..

^a UNIVERSITY OF BARCELONA   (Spain)

^b Ministérioda Saúde   (Mozambique)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^e IFAKARA HEALTH INSTITUTE   (Tanzania)

Author keywords

[No Author keywords available]

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; CD3 ANTIGEN; CD4 ANTIGEN; CD8 ANTIGEN; COTRIMOXAZOLE; HEMOGLOBIN; MEFLOQUINE; QUININE; ANTIMALARIAL AGENT;

ARTICLE; BED NET; CD4 T CELL COUNT TEST; CONGENITAL MALFORMATION; CONTROLLED STUDY; DISEASE TRANSMISSION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FLOW CYTOMETRY; FOLLOW UP; HIV RAPID TEST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALARIA; PARASITE EXAMINATION; PARASITEMIA; PLACENTA MALARIA; PLASMODIUM FALCIPARUM; POLYMERASE CHAIN REACTION; PREGNANCY; PREMATURITY; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REAGIN TEST; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SPONTANEOUS ABORTION; VIRUS LOAD; VOMITING; ADULT; CLINICAL TRIAL; HIV INFECTIONS; KENYA; MOZAMBIQUE; MULTICENTER STUDY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY COMPLICATIONS, PARASITIC; PREGNANCY OUTCOME; PREVENTION AND CONTROL; TANZANIA; TREATMENT OUTCOME; VERTICAL TRANSMISSION; YOUNG ADULT;

ADULT; ANTIMALARIALS; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HIV INFECTIONS; HUMANS; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; KENYA; MALARIA; MEFLOQUINE; MOZAMBIQUE; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY COMPLICATIONS, PARASITIC; PREGNANCY OUTCOME; TANZANIA; TREATMENT OUTCOME; TRIMETHOPRIM-SULFAMETHOXAZOLE COMBINATION; YOUNG ADULT;

EID: 84907960450     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001735     Document Type: Article

References (66)

1. Gonzalez R, Ataide R, Naniche D, Menendez C, Mayor A, (2012) HIV and malaria interactions: where do we stand? Expert Rev Anti Infect Ther 10: 153–165.
2. ter Kuile FO, Parise ME, Verhoeff FH, Udhayakumar V, Newman RD, et al. (2004) The burden of co-infection with human immunodeficiency virus type 1 and malaria in pregnant women in sub-saharan Africa. Am J Trop Med Hyg 71: 41–54.
3. Uneke CJ, Ogbonna A, (2009) Malaria and HIV co-infection in pregnancy in sub-Saharan Africa: impact of treatment using antimalarial and antiretroviral agents. Trans R Soc Trop Med Hyg 103: 761–767.
4. van Eijk AM, Ayisi JG, ter Kuile FO, Misore AO, Otieno JA, et al. (2003) HIV increases the risk of malaria in women of all gravidities in Kisumu, Kenya. AIDS 17: 595–603.
5. Mayor A, Kumar U, Bardaji A, Gupta P, Jimenez A, et al. (2013) Improved pregnancy outcomes in women exposed to malaria with high antibody levels against Plasmodium falciparum. J Infect Dis 207: 1664–1674.
6. Menendez C, D'Alessandro U, ter Kuile FO, (2007) Reducing the burden of malaria in pregnancy by preventive strategies. Lancet Infect Dis 7: 126–135.
7. Menendez C, Bardaji A, Sigauque B, Romagosa C, Sanz S, et al. (2008) A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic. PLoS ONE 3: e1934.
8. WHO (2012) Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP). Updated WHO Policy Recommendation. WHO Available: http://www.who.int/malaria/iptp_sp_updated_policy_recommendation_en_102012.pdf
9. WHO (2004) A strategic framework for malaria prevention and control during pregnancy in the African region. Geneva: World Health Organization. AFR/MAL/04/01.
10. WHO (2013) Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection Recommendations for a public health approach June 2013. Geneva: World Health Organization.
11. Sevene E, Gonzalez R, Menendez C, (2010) Current knowledge and challenges of antimalarial drugs for treatment and prevention in pregnancy. Expert Opin Pharmacother 11: 1277–1293.
12. Ward SA, Sevene EJ, Hastings IM, Nosten F, McGready R, (2007) Antimalarial drugs and pregnancy: safety, pharmacokinetics, and pharmacovigilance. Lancet Infect Dis 7: 136–144.
13. Daramola OO, Alonso PL, O'Dempsey TJ, Twumasi P, McArdle TF, et al. (1991) Sensitivity of Plasmodium falciparum in The Gambia to co-trimoxazole. Trans R Soc Trop Med Hyg 85: 345–348.
14. Anglaret X, Messou E, Ouassa T, Toure S, Dakoury-Dogbo N, et al. (2003) Pattern of bacterial diseases in a cohort of HIV-1 infected adults receiving cotrimoxazole prophylaxis in Abidjan, Cote d'Ivoire. AIDS 17: 575–584.
15. Ramharter M, Wernsdorfer WH, Kremsner PG, (2004) In vitro activity of quinolines against Plasmodium falciparum in Gabon. Acta Trop 90: 55–60.
16. Uhlemann AC, Ramharter M, Lell B, Kremsner PG, Krishna S, (2005) Amplification of Plasmodium falciparum multidrug resistance gene 1 in isolates from Gabon. J Infect Dis 192: 1830–1835.
17. Aubouy A, Fievet N, Bertin G, Sagbo JC, Kossou H, et al. (2007) Dramatically decreased therapeutic efficacy of chloroquine and sulfadoxine-pyrimethamine, but not mefloquine, in southern Benin. Trop Med Int Health 12: 886–894.
18. CDC (2011) Update: new recommendations for mefloquine use in pregnancy. Available: http://www.cdc.gov/malaria/new_info/2011/mefloquine_pregnancy.html. Accessed July 2013.
19. FDA (2013) FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve effects. Available: http://wwwfdagov/Drugs/DrugSafety/ucm362227htm. Accessed July 2013.
20. McGready R, Cho T, Hkirijaroen L, Simpson J, Chongsuphajaisiddhi T, et al. (1998) Quinine and mefloquine in the treatment of multidrug-resistant Plasmodium falciparum malaria in pregnancy. Ann Trop Med Parasitol 92: 643–653.
21. Briand V, Bottero J, Noel H, Masse V, Cordel H, et al. (2009) Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine. J Infect Dis 200: 991–1001.
22. Denoeud-Ndam L, Clement MC, Briand V, Akakpo J, Agossou VK, et al. (2012) Tolerability of mefloquine intermittent preventive treatment for malaria in HIV-infected pregnant women in Benin. J Acquir Immune Defic Syndr 61: 64–72.
23. Denoeud-Ndam L, Zannou DM, Fourcade C, Taron-Brocard C, Porcher R, et al. (2014) Cotrimoxazole prophylaxis versus mefloquine intermittent preventive treatment to prevent malaria in HIV-infected pregnant women: two randomized controlled trials. J Acquir Immune Defic Syndr 65: 198–206.
24. van Eijk AM, Ayisi JG, ter Kuile FO, Otieno JA, Misore AO, et al. (2004) Effectiveness of intermittent preventive treatment with sulphadoxine-pyrimethamine for control of malaria in pregnancy in western Kenya: a hospital-based study. Trop Med Int Health 9: 351–360.
25. González R, Mombo-Ngoma G, Ouédraogo S, Kakolwa MA, Abdulla S, et al. (2014) Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. PLoS Med 11: e1001733.
26. Ministry of Health and Social Welfare-The United Republic of Tanzania (2007) National Guidelines Prevention of Mother-to-Child Transmission of HIV. Ministry of Health of The United Republic of Tanzania.
27. Ministry of Health-Republic of Kenya (2009) Guidelines for the prevention of Mother to Child transmission (PMTCT) of HIV/AIDS in Kenya. Ministry of Health-Kenya.
28. Ministério da Saúde-República de Moçambique (2013) Introduçao de Novas Normas para o seguimiento do paciente HIV positivo. Direcçao Nacional de Assistencia Médica Ministério da Saúde de Moçambique.
29. Ballard JL, Khoury JC, Wedig K, Wang L, Eilers-Walsman BL, et al. (1991) New Ballard Score, expanded to include extremely premature infants. J Pediatr 119: 417–423.
30. Greenwood AM, Armstrong JR, Byass P, Snow RW, Greenwood BM, (1992) Malaria chemoprophylaxis, birth weight and child survival. Trans R Soc Trop Med Hyg 86: 483–485.
31. Planche T, Krishna S, Kombila M, Engel K, Faucher JF, et al. (2001) Comparison of methods for the rapid laboratory assessment of children with malaria. Am J Trop Med Hyg 65: 599–602.
32. Swysen C, Vekemans J, Bruls M, Oyakhirome S, Drakeley C, et al. (2011) Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine. Malar J 10: 223.
33. Alonso PL, Smith T, Schellenberg JR, Masanja H, Mwankusye S, et al. (1994) Randomised trial of efficacy of SPf66 vaccine against Plasmodium falciparum malaria in children in southern Tanzania. Lancet 344: 1175–1181.
34. Mayor A, Serra-Casas E, Bardaji A, Sanz S, Puyol L, et al. (2009) Sub-microscopic infections and long-term recrudescence of Plasmodium falciparum in Mozambican pregnant women. Malar J 8: 9.
35. Ordi J, Ismail MR, Ventura PJ, Kahigwa E, Hirt R, et al. (1998) Massive chronic intervillositis of the placenta associated with malaria infection. Am J Surg Pathol 22: 1006–1011.
36. Rogerson SJ, Mkundika P, Kanjala MK, (2003) Diagnosis of Plasmodium falciparum malaria at delivery: comparison of blood film preparation methods and of blood films with histology. J Clin Microbiol 41: 1370–1374.
37. Zou G, (2004) A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol 159: 702–706.
38. Bardaji A, Sigauque B, Bruni L, Romagosa C, Sanz S, et al. (2008) Clinical malaria in African pregnant women. Malar J 7: 27.
39. Tobin J, (1958) Estimation of relationships for limited dependent variables. Econometrica 26: 24–36.
40. Wooldridge JM (2012) Introductory econometrics: a modern approach. 5th edition. Cengage Learning.
41. WHO (2000) Safety monitoring of medicinal products. Guidelines for setting up and running a pharmacovigilance centre. WHO the Uppsala Monitoring Centre.
42. Ladner J, Leroy V, Simonon A, Karita E, Bogaerts J, et al. (2002) HIV infection, malaria, and pregnancy: a prospective cohort study in Kigali, Rwanda. Am J Trop Med Hyg 66: 56–60.
43. Rollins NC, Coovadia HM, Bland RM, Coutsoudis A, Bennish ML, et al. (2007) Pregnancy outcomes in HIV-infected and uninfected women in rural and urban South Africa. J Acquir Immune Defic Syndr 44: 321–328.
44. Menéndez C, Romagosa C, Ismail MR, Carrilho C, Saute F, et al. (2008) An autopsy study of maternal mortality in Mozambique: the contribution of infectious diseases. PLoS Med 5: e44.
45. Zaba B, Calvert C, Marston M, Isingo R, Nakiyingi-Miiro J, et al. (2013) Effect of HIV infection on pregnancy-related mortality in sub-Saharan Africa: secondary analyses of pooled community-based data from the network for Analysing Longitudinal Population-based HIV/AIDS data on Africa (ALPHA). Lancet 381: 1763–1771.
46. Sappenfield E, Jamieson DJ, Kourtis AP, (2013) Pregnancy and susceptibility to infectious diseases. Infect Dis Obstet Gynecol 2013: 752852.
47. Alonso PL, Lindsay SW, Armstrong Schellenberg JR, Keita K, Gomez P, et al. (1993) A malaria control trial using insecticide-treated bed nets and targeted chemoprophylaxis in a rural area of The Gambia, west Africa. 6. The impact of the interventions on mortality and morbidity from malaria. Trans R Soc Trop Med Hyg 87 Suppl 2: 37–44.
48. Nosten F, ter Kuile F, Maelankiri L, Chongsuphajaisiddhi T, Nopdonrattakoon L, et al. (1994) Mefloquine prophylaxis prevents malaria during pregnancy: a double-blind, placebo-controlled study. J Infect Dis 169: 595–603.
49. Schlagenhauf P, Adamcova M, Regep L, Schaerer MT, Rhein HG, (2010) The position of mefloquine as a 21st century malaria chemoprophylaxis. Malar J 9: 357.
50. Steketee RW, Wirima JJ, Slutsker L, Khoromana CO, Heymann DL, et al. (1996) Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine. Am J Trop Med Hyg 55: 50–56.
51. Gonzalez R, Hellgren U, Greenwood B, Menendez C, (2014) Mefloquine safety and tolerability in pregnancy: a systematic literature review. Malar J 13: 75.
52. Khaliq Y, Gallicano K, Tisdale C, Carignan G, Cooper C, et al. (2001) Pharmacokinetic interaction between mefloquine and ritonavir in healthy volunteers. Br J Clin Pharmacol 51: 591–600.
53. Byakika-Kibwika P, Lamorde M, Mayito J, Nabukeera L, Namakula R, et al. (2012) Significant pharmacokinetic interactions between artemether/lumefantrine and efavirenz or nevirapine in HIV-infected Ugandan adults. J Antimicrob Chemother 67: 2213–2221.
54. Byakika-Kibwika P, Lamorde M, Okaba-Kayom V, Mayanja-Kizza H, Katabira E, et al. (2012) Lopinavir/ritonavir significantly influences pharmacokinetic exposure of artemether/lumefantrine in HIV-infected Ugandan adults. J Antimicrob Chemother 67: 1217–1223.
55. German P, Parikh S, Lawrence J, Dorsey G, Rosenthal PJ, et al. (2009) Lopinavir/ritonavir affects pharmacokinetic exposure of artemether/lumefantrine in HIV-uninfected healthy volunteers. J Acquir Immune Defic Syndr 51: 424–429.
56. Kiang TK, Wilby KJ, Ensom MH, (2014) Clinical Pharmacokinetic Drug Interactions Associated with Artemisinin Derivatives and HIV-Antivirals. Clin Pharmacokinet 53: 141–153.
57. Kredo T, Mauff K, Van der Walt JS, Wiesner L, Maartens G, et al. (2011) Interaction between artemether-lumefantrine and nevirapine-based antiretroviral therapy in HIV-1-infected patients. Antimicrob Agents Chemother 55: 5616–5623.
58. Brachman PS, JrMetchock B, Kozarsky PE, (1992) Effects of antimalarial chemoprophylactic agents on the viability of the Ty21a typhoid vaccine strain. Clin Infect Dis 15: 1057–1058.
59. Horowitz H, Carbonaro CA, (1992) Inhibition of the Salmonella typhi oral vaccine strain, Ty21a, by mefloquine and chloroquine. J Infect Dis 166: 1462–1464.
60. Adachi E, Koibuchi T, Imai K, Kikuchi T, Koga M, et al. (2012) Favourable outcome of progressive multifocal leukoencephalopathy with mefloquine treatment in combination with antiretroviral therapy in an HIV-infected patient. Int J STD AIDS 23: 603–605.
61. Gofton TE, Al-Khotani A, O'Farrell B, Ang LC, McLachlan RS, (2011) Mefloquine in the treatment of progressive multifocal leukoencephalopathy. J Neurol Neurosurg Psychiatry 82: 452–455.
62. Moenster RP, Jett RA, (2012) Mirtazapine and mefloquine therapy for progressive multifocal leukoencephalopathy in a patient infected with human immunodeficiency virus. Am J Health Syst Pharm 69: 496–498.
63. Ezeamama A, Duggan C, Manji K, Spiegelman D, Hertzmark E, et al. (2014) Clinical malaria diagnosis in pregnancy in relation to early perinatal mother-to-child transmission of HIV: a prospective cohort study. HIV Med 15: 276–285.
64. UNAIDS/WHO (2010) Global report: UNAIDS report on the global AIDS Epidemic 2010. Joint United Nations Programme on HIV/AIDS UNAIDS/10.11E: (JC1958E).
65. WHO (2005) Technical Consultation on Malaria and HIV Interactions and Public Health Policy Implications (2004: Geneva, Switzerland) Malaria and HIV interactions and their implications for public health policy. Geneva: WHO.
66. MPAC (2013) Malaria Policy Advisory Committee to the WHO: conclusions and recommendations of September 2013 meeting. Malar J 12: 456.