At a glance
ClinicalIndex Comparison Record- ✓Ages 2–18 years
- ✓Confirmed HIV-1 infection (two positive assays from different samples ≥2 weeks apart)
- ✓Viral load >1500 RNA copies/mL
- ✓Acceptable baseline organ function (Grade ≤1 per DAIDS pediatric table, with exceptions for GGT, cholesterol, triglycerides ≤Grade 2)
- ✕Positive pregnancy test, breastfeeding, or unwilling to use two contraception methods (including ≥1 barrier method) for females of childbearing potential
- ✕Active hepatitis B or C with AST/ALT >Grade 2
- ✕Life expectancy <12 months
- ✕Unwillingness to avoid contraindicated substances (grapefruit juice, Seville oranges, St. John's Wort, milk thistle, garlic supplements)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
In Brief
A Phase 1 clinical trial evaluating TPV oral solution and RTV oral solution for HIV Infections. Completed, enrolled 115 participants across 30 sites in 10 countries.
Detailed Summary
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule. The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
Study Details
Timeline
Interventions
Tipranavir oral solution
Tipranavir oral solution
Ritonavir oral solution
Ritonavir oral solution