Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076999
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2004-02-09
Brief Title:
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus HIV-Infected Children
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Multiple-dose Open-label Randomized Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 TPVr in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPVr 500 mg 200 mg
The secondary objective of this study is the determination of the dose of topranavir and ritonavir TPVr in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPVr 500 mg 200 mg
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None