Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a double-blind randomised placebo-controlled trial.

Chintu, C; Bhat, G; Walker, A; Mulenga, V; Sinyinza, F; Lishimpi, K; Farrelly, L; Kaganson, N; Zumla, A; Gillespie, S; Nunn, A; Gibb, D

Journal article

Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a double-blind randomised placebo-controlled trial.

Abstract:: BACKGROUND: No trials of co-trimoxazole (trimethoprim-sulfamethoxazole) prophylaxis for HIV-infected adults or children have been done in areas with high levels of bacterial resistance to this antibiotic. We aimed to assess the efficacy of daily co-trimoxazole in such an area. METHODS: We did a double-blind randomised placebo-controlled trial in children aged 1-14 years with clinical features of HIV infection in Zambia. Primary outcomes were mortality and adverse events possibly related to treatment. Analysis was by intention to treat. FINDINGS: In October, 2003, the data and safety monitoring committee recommended early stopping of the trial. 541 children had been randomly assigned; seven were subsequently identified as HIV negative and excluded. After median follow-up of 19 months, 74 (28%) children in the co-trimoxazole group and 112 (42%) in the placebo group had died (hazard ratio [HR] 0.57 [95% CI 0.43-0.77], p=0.0002). This benefit applied in children followed up beyond 12 months (n=320, HR 0.48 [0.27-0.84], test for heterogeneity p=0.60) and across all ages (test for heterogeneity p=0.82) and baseline CD4 counts (test for heterogeneity p=0.36). 16 (6%) children in the co-trimoxazole group had grade 3 or 4 adverse events compared with 18 (7%) in the placebo group. These events included rash (one placebo), and a neutrophil count on one occasion less than 0.5x10(9)/L (16 [6%] co-trimoxazole vs seven [3%] placebo, p=0.06). Pneumocystis carinii was identified by immunofluorescence in only one (placebo) of 73 nasopharyngeal aspirates from children with pneumonia. INTERPRETATION: Our results suggest that children of all ages with clinical features of HIV infection should receive co-trimoxazole prophylaxis in resource-poor settings, irrespective of local resistance to this drug.

Publication status:: Published

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APA Style

Chintu, C., Bhat, G., Walker, A., Mulenga, V., Sinyinza, F., Lishimpi, K., Farrelly, L., Kaganson, N., Zumla, A., Gillespie, S., Nunn, A., & Gibb, D. (2004). Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a double-blind randomised placebo-controlled trial. Lancet (London, England), 364(9448), 1865–1871.

MLA Style

Chintu, C., et al. “Co-Trimoxazole as Prophylaxis against Opportunistic Infections in HIV-Infected Zambian Children (CHAP): a Double-Blind Randomised Placebo-Controlled Trial.” Lancet (London, England), vol. 364, no. 9448, 2004, pp. 1865–71.

Chicago Style

Chintu, C, G Bhat, A Walker, V Mulenga, F Sinyinza, K Lishimpi, L Farrelly, et al. 2004. “Co-Trimoxazole as Prophylaxis against Opportunistic Infections in HIV-Infected Zambian Children (CHAP): a Double-Blind Randomised Placebo-Controlled Trial.” Lancet (London, England) 364 (9448): 1865–71.
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