title: Safety and tolerability of antiretroviral therapy among HIV-infected children and adolescents in Uganda.
abstract: BACKGROUND
  Antiretroviral therapy (ART) is known to cause a number of adverse effects. The objective of this study was to determine the frequency and outcome of ART-related adverse events among patients aged 6 weeks to 18 years.
  
  
  METHODS
  We followed up a cohort of 378 HIV-infected children and adolescents who started ART at the Baylor-Uganda Clinic during the period 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.
  
  
  RESULTS
  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/night mares, 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.
  
  
  CONCLUSIONS
  Close to one-third of children on ART experience adverse events. Most events occur within the first 3 months of ART and are not associated with baseline patient characteristics.
authors: Research Unit, Baylor College of Medicine Bristol Myers Squibb Children's Clinical Center of Excellence at Mulago Hospital, Kampala, Uganda. vtukei@bayloruganda.org
authors: Vincent J
authors: VJ
authors: Tukei
authors: Alice
authors: A
authors: Asiimwe
authors: Albert
authors: A
authors: Maganda
authors: Rita
authors: R
authors: Atugonza
authors: Isaac
authors: I
authors: Sebuliba
authors: Sabrina
authors: S
authors: Bakeera-Kitaka
authors: Phillipa
authors: P
authors: Musoke
authors: Israel
authors: I
authors: Kalyesubula
authors: Adeodata
authors: A
authors: Kekitiinwa
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D006678:HIV; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007223:Infant; D053208:Kaplan-Meier Estimate; D011795:Surveys and Questionnaires; D014454:Uganda
chemical_list: D019380:Anti-HIV Agents