Protective efficacy of co-trimoxazole prophylaxis against malaria in HIV exposed children in rural Uganda: A randomised clinical trial

BMJ

Volumn 342, Issue 7801, 2011, Pages

  Sandison, Taylor G ^a   Homsy, Jaco ^b   Arinaitwe, Emmanuel ^c   Wanzira, Humphrey ^c   Kakuru, Abel ^c   Bigira, Victor ^c   Kalamya, Julius ^d   Vora, Neil ^e   Kublin, James ^f,g   Kamya, Moses R ^h   Grant Dorsey, ^e   Tappero, Jordan W ⁱ  

^a UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c INFECTIOUS DISEASES RESEARCH COLLABORATION   (Uganda)

^d Centers for Disease Control Uganda   (Uganda)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f Fred Hutchinson Cancer Research Center   (United States)

^g UNIVERSITY OF WASHINGTON   (United States)

^h MAKERERE UNIVERSITY MEDICAL SCHOOL   (Uganda)

ⁱ CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COTRIMOXAZOLE;

ANAMNESIS; ANTIBIOTIC PROPHYLAXIS; ARTICLE; BLOOD SMEAR; CHILD; CONTROLLED STUDY; DIARRHEA; DISEASE TRANSMISSION; DRUG EFFICACY; FEMALE; FEVER; GENE MUTATION; GENOTYPE; HOSPITALIZATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INCIDENCE; LABORATORY TEST; MAJOR CLINICAL STUDY; MALARIA; MALE; OUTCOME ASSESSMENT; PHYSICAL EXAMINATION; PLASMODIUM; PLASMODIUM MALARIAE; PLASMODIUM OVALE; PLASMODIUM VIVAX; PNEUMONIA; PRESCHOOL CHILD; PREVALENCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RURAL AREA; UGANDA;

ANTIMALARIALS; BREAST FEEDING; DIARRHEA, INFANTILE; FEMALE; HIV INFECTIONS; HIV SERONEGATIVITY; HUMANS; INCIDENCE; INFANT; MALARIA; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; RESPIRATORY TRACT INFECTIONS; RURAL HEALTH; TREATMENT OUTCOME; TRIMETHOPRIM-SULFAMETHOXAZOLE COMBINATION; UGANDA;

EID: 84858998763     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.d1617     Document Type: Article

References (55)

1. World Health Organization & Roll Back Malaria. Malaria and HIV interactions and their implications for public health policy. Report of a technical consultation, Geneva, Switzerland, 23-5 June 2004. 2010. www.who.int/hiv/pub/prev-care/malariahiv.pdf.
2. Joint United Nations Programme on HIV/AIDS, (UNAIDS) & World Health Organization (WHO). AIDS epidemic update: November 2009. UNAIDS and WHO, 2009.
3. Brahmbhatt H, Kigozi G, Wabwire-Mangen F, Serwadda D, Lutalo T, Nalugoda F, et al. Mortality in HIV-infected and uninfected children of HIV-infected and uninfected mothers in rural Uganda. J Acquir Immune Defic Syndr 2006;41:504-8.
4. Crampin AC, Floyd S, Glynn JR, Madise N, Nyondo A, Khondowe MM, et al. The long-term impact of HIV and orphanhood on the mortality and physical well-being ofchildren in rural Malawi. Aids 2003;17:389-97. (Pubitemid 36223263)
5. Kuhn L, Kasonde P, Sinkala M, Kankasa C, Semrau K, Scott N, et al. Does severity of HIV disease in HIV-infected mothers affect mortality and morbidity among their uninfected infants? Clin Infect Dis 2005;41:1654-61. (Pubitemid 41691606)
6. Kamya MR, Gasasira AF, Achan J, Mebrahtu T , Ruel T , Kekitiinwa A, et al. Effects of trimethoprim-sulfamethoxazole and insecticidetreated bednets on malaria among HIV-infected Ugandan children. Aids 2007;21:2059-66. (Pubitemid 47462155)
7. Mermin J, Ekwaru JP, Liechty CA, Were W, Downing R, Ransom R, et al. Effect of co-trimoxazole prophylaxis, antiretroviral therapy, and insecticide-treated bednets on the frequency of malaria in HIV-1-infected adults in Uganda: a prospective cohort study. Lancet 2006;367:1256-61.
8. Thera MA, Sehdev PS, Coulibaly D, Traore K, Garba MN, Cissoko Y, et al. Impact of trimethoprim-sulfamethoxazole prophylaxis on falciparum malaria infection and disease. J Infect Dis 2005;192:1823-9. (Pubitemid 41587836)
9. Mermin J, Lule J, Ekwaru J P, Downing R, Hughes P, Bunnell R, et al. Cotrimoxazole prophylaxis by HIV-infected persons in Uganda reduces morbidity and mortality among HIV-uninfected family members. Aids 2005;19:1035-42. (Pubitemid 40961143)
10. World Health Organization. Guidelines on cotrimoxazole prophylaxis for HIV-related infections among children, adolescents and adults: recommendations for a public health approach. WHO, 2006.
11. Anglaret X, Chene G, Attia A, Toure S, Lafont S, Combe P, et al. Early chemoprophylaxis with trimethoprim-sulphamethoxazole for HIV-1-infected adults in Abidjan, Cote d'Ivoire: a randomised trial. Cotrimo-CI Study Group. Lancet 1999;353:1463-8. (Pubitemid 29204363)
12. Chintu C, Bhat GJ, Walker AS, Mulenga V, Sinyinza F, Lishimpi K, et al. Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a double-blind randomised placebo-controlled trial. Lancet 2004;364:1865-71. (Pubitemid 39536090)
13. Wiktor SZ, Sassan-Morokro M, Grant AD, Abouya L, Karon JM, Maurice C, et al. Efficacy of trimethoprim-sulphamethoxazole prophylaxis to decrease morbidityand mortalityin HIV-1-infected patients with tuberculosis in Abidjan, Cote d'Ivoire: a randomised controlled trial. Lancet 1999;353:1469-75. (Pubitemid 29204364)
14. Gill CJ, Sabin LL, Tham J, Hamer DH. Reconsidering empirical cotrimoxazole prophylaxis for infants exposed to HIV infection. Bull World Health Organ 2004;82:290-7. (Pubitemid 38568466)
15. Santmyire BR. Vertical transmission of HIV from motherto child in sub-Saharan Africa: modes of transmission and methods for prevention. Obstet Gynecol Surv 2001;56:306-12. (Pubitemid 32405840)
16. Wilfert CM, Fowler MG. Balancing maternal and infant benefits and the consequences ofbreast-feedingin the developingworld during the era of HIV infection. J InfectDis 2007;195:165-7. (Pubitemid 46080046)
17. Okello PE, Van Bortel W, Byaruhanga AM, Correwyn A, Roelants P, Talisuna A, et al. Variation in malaria transmission intensityin seven sites throughout Uganda. Am J Trop Med Hyg 2006;75:219-25. (Pubitemid 46941334)
18. World Health Organization. WHO guidelines on infant feeding: principles and recommendations for infant feeding in the context of HIV and a summary of the evidence. 2010. http://whqlibdoc.who.int/publications/2010/9789241599535- eng.pdf.
19. International Conference on Harmonisation. ICH harmonised tripartite guideline. Clinical safety data management: definitions and standards for expedited reporting E2A. ICH, 1994.
20. World Health Organization. WHO guidelines for the treatment of malaria, 2006. WHO, 2006.
21. Arinaitwe E, Sandison TG, Wanzira H, Kakuru A, Homsy J, Kalamya J, et al. Artemether-lumefantrine versus dihydroartemisininpiperaquine for falciparum malaria: a longitudinal, randomized trial in young Ugandan children. Clin InfectDis 2009;49:1629-37.
22. Uganda Ministry of Health. Uganda national policy guidelines for HIV voluntary counselling and testing. Uganda Ministry of Health, 2005.
23. Snounou G, Viriyakosol S, Jarra W, Thaithong S, Brown KN. Identification of the four human malaria parasite species in field samples bythe polymerase chain reaction and detection ofa high prevalence of mixed infections. Mol Biochem Parasitol 1993;58:283-92.
24. Duraisingh MT, Curtis J, Warhurst DC. Plasmodium falciparum: detection of polymorphisms in the dihydrofolate reductase and dihydropteroate synthetase genes by PCR and restriction digestion. Exp Parasitol 1998;89:1-8. (Pubitemid 28377366)
25. Kyabayinze D, Cattamanchi A, Kamya MR, Rosenthal PJ, Dorsey G. Validation of a simplified method for using molecular markers to predict sulfadoxine-pyrimethamine treatment failure in African children with falciparum malaria. Am JTrop Med Hyg 2003;69:247-52.
26. Plowe CV, Djimde A, Bouare M, Doumbo O, Wellems TE. Pyrimethamine and proguanil resistance-conferring mutations in Plasmodium falciparum dihydrofolate reductase: polymerase chain reaction methods for surveillance in Africa. Am J Trop Med Hyg 1995;52:565-8.
27. Sibley CH, Hyde JE, Sims PF, Plowe CV, Kublin JG, Mberu EK, et al. Pyrimethamine-sulfadoxine resistance in Plasmodium falciparum: what next? Trends Parasitol 2001;17:582-8. (Pubitemid 34088118)
28. AIDS epidemic update: December 2005, Sub-Saharan Africa. 2005. www.unaids.org/epi/2005/doc/EPIupdate2005-pdf-en/Epi05-05-en.pdf.
29. Nahum A, Erhart A, Ahounou D, Bonou D, Van Overmeir C, Menten J, et al. Extended high efficacy of the combination sulphadoxinepyrimethamine with artesunate in children with uncomplicated falciparum malaria on the Benin coast, West Africa. Malar J 2009;8:37.
30. Tinto H, Ouedraogo JB, Zongo I, van Overmeir C, van Marck E, Guiguemde TR, et al. Sulfadoxine-pyrimethamine efficacy and selection of Plasmodium falciparum DHFR mutations in Burkina Faso before its introduction as intermittent preventive treatment for pregnant women. Am J Trop Med Hyg 2007;76:608-13. (Pubitemid 351627694)
31. Faucher J F, Binder R, Missinou MA, Matsiegui PB, Gruss H, Neubauer R, et al. Efficacy of atovaquone/proguanil for malaria prophylaxis in children and its effecton the immunogenicity of live oral typhoid and cholera vaccines. Clin Infect Dis 2002; 35:1147-54. (Pubitemid 35305861)
32. Greenwood BM, Greenwood AM, Bradley AK, Snow RW, Byass P, Hayes RJ, et al. Comparison of two strategies for control of malaria within a primaryhealth care programme in the Gambia. Lancet 1988;1:1121-7.
33. Hogh B, Thompson R, Lobo V, Dgedge M, Dziegiel M, Borre M, et al. The influence of Maloprim chemoprophylaxis on cellular and humoral immune responses to Plasmodium falciparum asexual blood stage antigens in schoolchildren living in a malaria endemic area of Mozambique. Acta Trop 1994;57:265-77.
34. Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, et al. Randomised placebo-controlled trial ofiron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet 1997;350:844-50. (Pubitemid 27404345)
35. Watkins WM, Brandling-Bennett AD, Oloo AJ, Howells RE, Gilles HM, Koech DK. Inadequacy of chlorproguanil 20 mg perweek as chemoprophylaxis for falciparum malaria in Kenya. Lancet 1987;1:125-8.
36. Wolde B, Pickering J, Wotton K. Chloroquine chemoprophylaxis in children duringpeak transmission period in Ethiopia. J Trop Med Hyg 1994;97:215-8. (Pubitemid 24247366)
37. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Aide P, et al. Duration of protection with RTS, S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up ofa randomised controlled trial. Lancet 2005;366:2012-8. (Pubitemid 41773376)
38. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Milman J, et al. Efficacy of the RTS, S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet 2004;364:1411-20. (Pubitemid 39370716)
39. Aponte JJ, Aide P, Renom M, Mandomando I, Bassat Q, Sacarlal J, et al. Safety of the RTS, S/AS02D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomised controlled phase I/IIb trial. Lancet 2007;370:1543-51. (Pubitemid 350018877)
40. Aponte JJ, Schellenberg D, Egan A, Breckenridge A, Carneiro I, Critchley J, et al. Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials. Lancet 2009;374:1533-42.
41. Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, et al. Efficacy of RTS, S/AS01E vaccine against malaria in children 5 to 17 months of age. N Engl J Med 2008;359:2521-32.
42. Sacarlal J, Aide P, Aponte JJ, Renom M, Leach A, Mandomando I, et al. Long-term safetyand efficacy of the RTS, S/AS02A malaria vaccine in Mozambican children. J Infect Dis 2009;200:329-36.
43. Cairns M, Gosling R, Carneiro I, Gesase S, Mosha JF, Hashim R, et al. Duration of protection against clinical malaria provided by three regimens of intermittent preventive treatment in Tanzanian infants. PLoS One 2010;5:e9467.
44. Iyer J K, Milhous WK, Cortese JF, Kublin JG, Plowe CV. Plasmodium falciparum cross-resistance between trimethoprim and pyrimethamine. Lancet 2001;358:1066-7. (Pubitemid 32925132)
45. Triglia T, Menting JG, Wilson C, Cowman AF. Mutations in dihydropteroate synthase are responsible for sulfone and sulfonamide resistance in Plasmodium falciparum. Proc Natl Acad SciUSA1997;94:13944-9. (Pubitemid 28009689)
46. Lynen L, Jacobs J, Colebunders R. Co-trimoxazole prophylaxis in tropical countries in the era of highly active antiretroviral therapy: do we know enough? Trans RSoc Trop Med Hyg 2007;101:1059-60. (Pubitemid 47440539)
47. Gasasira AF, Kamya MR, Ochong EO, Vora N, Achan J, Charlebois E, et al. Effect of trimethoprim-sulphamethoxazole on the risk of malaria in HIV-infected Ugandan children living in an area of widespread antifolate resistance. Malar J 2010;9:177.
48. Malamba S , Sandison T, Lule J, Reingold A, Walker J, Dorsey G, et al. Plasmodium falciparum dihydrofolate reductase and dihyropteroate synthase mutations and the use of trimethoprim-sulfamethoxazole prophylaxis among persons infected with human immunodeficiency virus. Am J Trop Med Hyg 2010;82:766-71.
49. Dorsey G, Dokomajilar C, Kiggundu M, Staedke SG, Kamya MR, Rosenthal PJ. Principal role of dihydropteroate synthase mutations in mediating resistance to sulfadoxine-pyrimethamine in single-drug and combination therapy of uncomplicated malaria in Uganda. Am J Trop Med Hyg 2004;71:758-63. (Pubitemid 40075626)
50. Kublin JG, Dzinjalamala FK, Kamwendo DD, Malkin EM, Cortese JF, Martino LM, et al. Molecular markers for failure of sulfadoxinepyrimethamine and chlorproguanil-dapsone treatment of Plasmodium falciparum malaria. J InfectDis 2002;185:380-8. (Pubitemid 34107252)
51. Chatterjee A, Bosch RJ, Hunter DJ, Fataki MR, Msamanga GI, Fawzi WW. Maternal disease stage and child undernutrition in relation to mortality among children born to HIV-infected women in Tanzania. J Acquir Immune Defic Syndr 2007;46:599-606. (Pubitemid 350191054)
52. Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet 2004;364:1236-43. (Pubitemid 39311344)
53. Kuhn L, Thea DM, Aldrovandi GM. Bystander effects: children who escape infection but not harm. J Acquir Immune Defic Syndr 2007;46:517-8. (Pubitemid 350191043)
54. Marinda E, Humphrey JH, Iliff PJ, Mutasa K, Nathoo KJ, Piwoz EG, et al. Child mortality according to maternal and infant HIV status in Zimbabwe. Pediatr Infect Dis J 2007;26:519-26. (Pubitemid 46847314)
55. McIntyre J. Use of antiretrovirals during pregnancy and breastfeeding in low-income and middle-income countries. CurrOpin HIV AIDS;5:48-53.