Summary

Design:                       Randomized clinical trial involving hospitalized HIV-1 infected children.  Children will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy (7-14 days).  This trial will be unblinded.

Population:                Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve ≤ 12 years of age.

Sample size:              360 children will be randomized (180 per arm). 

Treatment:                 All children will be treated with ART according to World Health Organization (WHO) and Kenyan national guidelines.   

Study duration:         Enrollment into the study will occur over the course of 36-48 months and each child will be routinely followed for a maximum of 6 months.

Study sites:               Kenyatta National Hospital, Kisumu District Hospital, Nyanza Provincial Hospital)