title: Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience.
abstract: BACKGROUND
  To evaluate the long-term (up to week 292) safety, efficacy and tolerability of ritonavir-boosted tipranavir in HIV-1-infected pediatric patients. Long-term follow up of patients enrolled in the randomized, open-label pediatric trial (1182.14/PACTG1051).
  
  
  METHODS
  HIV-1-infected pediatric patients (2-18 years) who participated in the PACTG 1051 trial were followed for ritonavir-boosted tipranavir-based regimen efficacy, safety and tolerability through week 292.
  
  
  RESULTS
  In patients <12 years of age, 51/62 (82%) were receiving drug at week 48 and 13/62 (21%) at week 288. Among adolescents (12-18 years of age), 35/53 (66%) were receiving drug at week 48 and 2/53 (4%) at week 288. Among patients 2 to <6 years of age, 18/25 (72%) had viral loads <400 copies/mL at week 48. By week 292, 9/25 (36%) of patients had viral loads <400 copies/mL. Among older patients, week 48 responder rates were 35% (13/37 of patients 6 to <12 years of age) and 32% (17/53 of patients 12 to 18 years of age). By week 292, 6/37 (16%) of those 6 to <12 years of age and 2/53 (4%) of those 12 to 18 years of age had viral loads <400 copies/mL. Overall safety and tolerability profiles were best for children who initiated treatment between 2 and <6 years of age. Drug-related adverse events (investigator defined) were similar across all age groups (55-65%).
  
  
  CONCLUSIONS
  Pediatric patients who begin treatment at the earlier ages, and who are stable on a ritonavir-boosted tipranavir-based regimen at week 48, generally continue to demonstrate good safety, tolerability and virologic efficacy profiles up to 292 weeks of treatment.
authors.affiliation: From the *Connecticut Children's Medical Center, Division of Pediatric Infectious Diseases and Departments of Pediatrics and Immunology, University of Connecticut School of Medicine, Hartford, CT; †Fundación Huésped, Buenos Aires, Argentina; ‡Instituto de Infectologia Emílio Ribas; §Department of Pediatrics, University of São Paulo Medical School, São Paulo, Brazil; and ¶Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT.
authors.forename: Juan C
authors.initials: JC
authors.lastname: Salazar
authors.forename: Pedro
authors.initials: P
authors.lastname: Cahn
authors.forename: Marinella
authors.initials: M
authors.lastname: Della Negra
authors.forename: Maria Zilda
authors.initials: MZ
authors.lastname: De Aquino
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Robinson
authors.forename: Ante
authors.initials: A
authors.lastname: Jelaska
authors.forename: Jaromir
authors.initials: J
authors.lastname: Mikl
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1; D006801:Humans; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D011753:Pyrones / Q000008:administration & dosage* / Q000009:adverse effects; D019438:Ritonavir / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D011725:Pyridines; D011753:Pyrones; D013449:Sulfonamides; D019438:Ritonavir; C107201:tipranavir