Efficacy and Safety of Tipranavir Co-Administered with Ritonavir in HIV-1-Infected Children and Adolescents: 5 Years of Experience

dc.contributor.authorSalazar, Juan Carlos
dc.contributor.authorCahn, Pedro
dc.contributor.authorDella Negra, Marinella
dc.contributor.authorDe Aquino, Maria Zilda
dc.contributor.authorRobinson, Patrick
dc.contributor.authorJelaska, Ante
dc.contributor.authorMikl, Jaromir
dc.date.accessioned2024-05-23T15:24:12Z
dc.date.available2024-05-23T15:24:12Z
dc.date.issued2014
dc.description.abstractBackground: 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.
dc.identifier.citationSalazar, J. C., Cahn, P., Della Negra, M., De Aquino, M. Z., Robinson, P. A., Jelaska, A., & Mikl, J. (2014). Efficacy and safety of Tipranavir coadministered with Ritonavir in HIV-1-infected children and adolescents. The Pediatric Infectious Disease Journal.
dc.identifier.otherDOI: 10.1097/INF.0000000000000038
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1061
dc.relation.ispartofseriesThe Pediatric Infectious Disease Journal
dc.subjectTipranavir efficacy
dc.subjectPediatric HIV
dc.subjectAntiretroviral safety
dc.titleEfficacy and Safety of Tipranavir Co-Administered with Ritonavir in HIV-1-Infected Children and Adolescents: 5 Years of Experience

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