Co-trimoxazole prophylaxis against opportunistic infections is safe, and effective in HIV-infected children

ARTICLE IN PRESS Evidence-Based Healthcare & Public Health (2005) 9, 235–236

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EVIDENCE-BASED PUBLIC HEALTH

Co-trimoxazole prophylaxis against opportunistic infections is safe, and effective in HIV-infected children$

KEYWORDS Co-trimoxazole; HIV; Children; Zambia prophylaxis.

Question: Does co-trimoxazole prophylaxis against opportunistic infections reduce mortality and hospital admissions in HIV-infected children more than 1 year old? Study design: Double blind randomised controlled trial. Main results: In HIV-infected children more than 1 year old, co-trimoxazole prophylaxis against opportunistic infections reduced deaths and hospital admissions compared with placebo at nearly 19 months. The number of treatment related adverse events were similar in both groups (see results table). Authors’ conclusions: Children with HIV infection should receive cotrimoxazole prophylaxis in resource-poor settings, despite local bacterial resistance to this drug. & 2005 Published by Elsevier Ltd.

Further details Setting One hospital in Zambia from May 2001 to October 2003. Participants 541 HIV positive children. Children were excluded if they had an opportunistic infection, a life expectancy less than 4 weeks, current treatment with or allergic to co-trimoxazole, or previous P. carinii pneumonia. HIV tests were repeated in children at 18 months of age; if negative, co-trimoxazole treatment was stopped and they were excluded from the analysis. Intervention Children were randomised to receive 230 mg/day of co-trimoxazole if r5 years of age and 480 mg/day if Z5 years of age, or placebo for nearly 19 months. Main outcomes Deaths; laboratory or clinical adverse events; hospital admission rates.

$ Abstracted from: Chintu C, Bhat GJ, Walker AS 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.

1744-2249/$ - see front matter & 2005 Published by Elsevier Ltd. doi:10.1016/j.ehbc.2005.03.005

ARTICLE IN PRESS 236

EVIDENCE-BASED PUBLIC HEALTH

Results table Deaths, hospital admissions and adverse events at nearly 19 months. Outcome

Co-trimoxazole (n ¼ 265)

Placebo (n ¼ 269)

HR (95% CI)

Death Hospital admission Grade 3 or 4 treatmentrelated adverse event

74 (28%) 119 (45%) 16 (6%)

112 (42%) 159 (59%) 18 (7%)

0.57 (0.43 to 0.77) 0.64 (0.51 to 0.82) Not stated

Notes There were three amendments to the study protocol. In July 2001, children r12 months of age were excluded and children r15 years included. In October 2002, the target recruitment was reduced from 700 to 540 children due to a higher event rate and lower dropout rate than expected. In October 2003, the trial was stopped prematurely, since continued benefit with co-trixomazole was observed. 114 (43%) children in the co-trimoxazole group and 122 (46%) in the placebo group received open-label co-trimoxazole at some point during the study. Sources of funding: Department for International Development, UK. Abstract provided by Bazian Ltd, London