Conditions: HIV Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 115
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: TPV and RTV oral solution low dose arm 2: TPV and RTV oral solution high dose

Interventions: intervention 1: TPV oral solution intervention 2: TPV oral solution intervention 3: RTV oral solution intervention 4: RTV oral solution
Intervention descriptions: intervention 1: Tipranavir oral solution intervention 2: Tipranavir oral solution intervention 3: Ritonavir oral solution intervention 4: Ritonavir oral solution

Protocol document: