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Pediatr Infect Dis J. 2014 Apr;33(4):396-400. doi: 10.1097/INF.0000000000000038.

Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience.

Author information

1
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.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00076999.

PMID:
23995585
DOI:
10.1097/INF.0000000000000038
[Indexed for MEDLINE]

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