Reduced bacterial skin infections in HIV-infected African children randomized to long-term cotrimoxazole prophylaxis

Objective:To evaluate whether cotrimoxazole prophylaxis prevents common skin conditions in HIV-infected children. Design:Open-label randomized controlled trial of continuing versus stopping daily cotrimoxazole (post-hoc analysis). Setting:Three sites in Uganda and one in Zimbabwe. Participants:A total of 758 children aged more than 3 years receiving antiretroviral therapy (ART) for more than 96 weeks in the ARROW trial were randomized to stop (n = 382) or continue (n = 376) cotrimoxazole after median (interquartile range) 2.1(1.8, 2.2) years on ART. Intervention:Continuing versus stopping daily cotrimoxazole. Main outcome measures:Nurses screened for signs/symptoms at 6-week visits. This was a secondary analysis of ARROW trial data, with skin complaints categorized blind to randomization as bacterial, fungal, or viral infections; dermatitis; pruritic papular eruptions (PPEs); or others (blisters, desquamation, ulcers, and urticaria). Proportions ever reporting each skin complaint were compared across randomized groups using logistic regression. Results:At randomization, median (interquartile range) age was 7 (4, 11) years and CD4+ was 33% (26, 39); 73% had WHO stage 3/4 disease. Fewer children continuing cotrimoxazole reported bacterial skin infections over median 2 years follow-up (15 versus 33%, respectively; P < 0.001), with similar trends for PPE (P = 0.06) and other skin complaints (P = 0.11), but not for fungal (P = 0.45) or viral (P = 0.23) infections or dermatitis (P = 1.0). Bacterial skin infections were also reported at significantly fewer clinic visits (1.2 versus 3.0%, P < 0.001). Independent of cotrimoxazole, bacterial skin infections were more common in children aged 6–8 years, with current CD4+ cell count less than 500 cells/&mgr;l, WHO stage 3/4, less time on ART, and lower socio-economic status. Conclusion:Long-term cotrimoxazole prophylaxis reduces common skin complaints, highlighting an additional benefit for long-term prophylaxis in sub-Saharan Africa.