This study hypothesizes that the combination of atovaquone/azithromycin will be equivalent to or superior to trimethoprim/sulfamethoxazole for the prevention of serious bacterial infection in HIV-infected children with depleted CD4 lymphocyte populations. After stratifying for previous use of TMP/SMX and/or IVIG, subjects are randomized to one of two arms: TMP/SMX (5 mg/kg/day) or micronized atovaquone (30 mg/kg/day) plus azithromycin (5 mg/kg/day). Cross-over to the alternative drug regimen will occur if a serious treatment-related toxicity is observed. The efficacy of the antibacterial regimens is being evaluated through monitoring the occurrence of serious bacterial infections or PCP break-through. Subjects will receive study drug until the last subject enrolled has completed 3 years or when there are 530, 475, and 420 subjects who have been followed for one, two and three years, respectively. The first 30 subjects were to have had a pharmacokinetics profile performed to assist in insuring that previously established blood concentrations of azithromycin and atovaquone were not significantly affected by the administration of the two drugs in combination.
Showing the most recent 10 out of 1014 publications