Abstract
BACKGROUND: The World Health Organization guidelines recommend cotrimoxazole prophylactic treatment (CPT) for all HIV-exposed infants from age 6 weeks to the cessation of breastfeeding and the exclusion of HIV infection. There are limited data on the effects of CPT among this population of infants. We examined the effects of CPT on adverse health outcomes among HIV-exposed infants during the first 36 weeks of life using data from the Breastfeeding, Antiretrovirals and Nutrition study, a large clinical trial of antiretroviral drugs given to the mother or infant for the prevention of HIV transmission during breastfeeding. METHODS: For the analysis, we assigned a status of CPT-exposed to infants who were participating in the study after the CPT program started. We estimated unadjusted and adjusted hazard ratios for the effect of CPT status on time to incident malaria, severe illness or death, anemia, and weight-for-age Z score < -2.0. Participation in the study was limited to focus exclusively on HIV-exposed, uninfected infants. RESULTS: The hazard ratio for the effect of CPT on incident malaria was 0.35 (95% confidence interval: 0.21, 0.57) during the first 10 weeks of CPT exposure and 0.93 (95% confidence interval: 0.67, 1.29) for the remaining 20 weeks. CPT was not associated with the other outcomes examined. CONCLUSIONS: CPT offered temporary protection against malaria among HIV-exposed, uninfected infants. However, CPT offered no protection against anemia, low weight for age or the collapsed outcome of severe illness or death.