Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents

Juan C. Salazar, Pedro Cahn, Ram Yogev, Marinella Della Negra, Guido Castelli-Gattinara, Claudia Fortuny, Patrica M. Flynn, Carlo Giaquinto, Ping K. Ruan, M. Elizabeth Smith, Jaromir Mikl, Ante Jelaska

Research output: Contribution to journalArticlepeer-review

34 Scopus citations

Abstract

OBJECTIVE: To evaluate the efficacy, safety and tolerability of ritonavir-boosted tipranavir (TPV/r) in HIV-1-infected pediatric patients. DESIGN: Open-label randomized pediatric trial (1182.14/PACTG1051) comparing TPV/r at two doses including an optimized background regimen. METHODS: HIV-1-infected patients (2-18 years) with plasma viral load 1500 copies/ml or more were randomized to TPV/r 290/115 or 375/150 mg/m twice-daily oral solution and optimized background regimen. Week 48 efficacy, safety and tolerability results were evaluated. RESULTS: Children (n ≤ 115; 97% treatment experienced) were randomized to low or high dose therapy. Eighty-eight remained on-treatment through 48 weeks. Baseline characteristics were similar between dose groups. At study entry, half of the HIV-1 isolates were resistant to all protease inhibitors. At 48 weeks, 39.7% low-dose and 45.6% high-dose TPV/r recipients had viral load less than 400 copies/ml and 34.5 and 35.1%, respectively, achieved viral load less than 50 copies/ml. Vomiting, cough and diarrhea were the most frequent adverse events. Grade 3 alanine aminotransferase elevations were observed in 6.3% of patients. No grade 4 alanine aminotransferase or grade 3/4 aspartate aminotransferase elevations were reported. CONCLUSIONS: TPV/r achieved a sustained virologic response, showed a good safety profile and was well tolerated at either dose. In pediatric patients with high baseline resistance profiles, high-dose TPV/r tended to demonstrate a better sustained response.

Original languageEnglish (US)
Pages (from-to)1789-1798
Number of pages10
JournalAIDS
Volume22
Issue number14
DOIs
StatePublished - Sep 12 2008

Keywords

  • Antiretroviral therapy
  • Efficacy
  • Pediatric
  • Protease inhibitor
  • Ritonavir
  • Safety
  • Tipranavir

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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