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The Drug Resource Enhancement against AIDS and Malnutrition (DREAM) program is a large antiretroviral therapy treatment program financed by the Treatment Acceleration Program (TAP) of the World Bank. In addition to provision of antiretroviral treatment to individuals infected with human immunodeficiency virus (HIV) in sub-Saharan Africa, one major aspect of the DREAM program is nutritional supplementation and prevention of mother-to-child transmission (PMTCT) of HIV.HIV-positive pregnant women enrolled in the DREAM program receive highly active antiretroviral therapy (HAART) free of charge from the 25th week of gestation, irrespective of clinical stage, CD4 count, and viral load. Their infants receive post-exposure prophylaxis. From 2004 to 2006, women enrolled in the DREAM program in Mozambique, Tanzania, and Malawi received water filters and formula for the first 6 months of lactation. In a second cohort starting in 2005 until 2006 in Mozambique, women received HAART for up to 6 months after delivery and were given the option to breastfeed. We conducted a comparative analysis of the two cohorts of HIV-positive pregnant women followed prospectively and evaluated HIV-1 mother-to-child transmission rates, infant morbidity, and mortality in both cohorts.In the first cohort, 879 live-born children were delivered, with 809 evaluable infants at 1 and 6 months. In the second cohort, 341 infants were delivered and evaluable at 1 month, and 251 infants were evaluable at 6 months. At age 1 month, HIV-1 transmission rates were 4/341 (1.2%) among breastfed infants and 7/809 (0.8%) among formula-fed infants. At age 6 months, HIV-1 mother-to-child transmission rates were 2/251 (0.8%) among breastfed infants of women receiving HAART and 15/809 (1.8%) among formula-fed infants (χ2 = 0.77, P = 0.38 [NS]). The cumulative incidence rate at 6 months of age was 2.7% for formula-fed infants and 2.2% for breastfed infants (χ2 = 0.27, P = 0.60 [NS]). There was a trend for HIV-1 infection rates to be slightly greater among formula-fed infants, but overall mother-to-child transmission rates in both cohorts were extremely low. Most infants did relatively well on both feeding regimens. Observed Z scores were greater than among the general infant population in the community. Z scores ≤2.0 for weight by age occurred in 92/809 formula-fed infants (11.4%) and in 28/251 breastfed infants (11.1%). The rates of anemia in the study infant population were also lower than that of the general population. A hemoglobin value <8 g/dl was found in 40/809 formula-fed infants (4.9%) and in 17/251 breastfed infants (6.8%) (χ2 = 0.92, P = 0.33). The mortality rate at 6 months of age was 27 per 1000 person-years among formula-fed infants and 28.5 per 1000 person-years in breastfed infants – both considerably lower than the rates of 101 per 1000 person-years observed in Mozambique.The DREAM HIV-1 PMTCT protocol was safe and efficacious in reducing transmission in infants of 1 and 6 months of age. Results were comparable to those from developed countries. Breastfeeding among HIV-1 infected mothers receiving HAART posed no additional risk of late postnatal HIV-1 transmission to the infant by 6 months of age.