Safety and tolerability of antiretroviral therapy among HIV-infected children and adolescents in Uganda.

The objective of this study was to determine the frequency and outcome of ART-related adverse events among patients ages 6 weeks to 18 years. The authors followed up a cohort of 378 HIV-infected children and adolescents who started ART at the Baylor-Uganda Clinic during the period of July 2004 to July 2009. Patients were started on zidovudine or stavudine plus lamivudine and efavirenz or nevirapine. Adverse events were recorded as they occurred. Descriptive analyses and Kaplan-Meier survival analysis were carried out. Of 126 adverse events reported among 107 (28.3%) patients dizziness (17.5%) diarrhea (13.5%) and nausea and vomiting (14.3%) were the most frequent. Anxiety nightmares skin rashes nail discoloration and lipodystrophy each contributed between 5% and 10%; whereas anorexia abdominal pain hepatitis and somnolence contributed 1%-5%. Amnesia lactic acidosis gynaecomastia cardiomyopathy and peripheral neuropathy were rare each contributing less than 1% of the total events. The overall probability of remaining free of adverse events was 77.1% (95% confidence interval: 72.38 to 81.13) at month 6 of ART. Among infants and young children neurologic events could not be determined. Laboratory abnormalities were present at baseline and during follow-up and hemoglobin levels increased significantly during the first 6 months of ART. There was no association between adverse events and baseline patient characteristics.