Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056641
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2003-03-19
Brief Title:
Dual Boosted - Protease Inhibitor PI Pharmacokinetics PK Trial Tipranavir Ritonavir in Highly Treatment-experienced HIV-1 Infected Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open Label Randomized Parallel-group Pharmacokinetics Trial of Tipranavir Ritonavir TPVRTV Alone or in Combination With RTV-boosted Saquinavir SQV Amprenavir APV or Lopinavir LPV Plus an Optimized Background Regimen in Multiple Antiretroviral ARV Experienced Patients
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This is an open-label randomized parallel group pharmacokinetics trial of tipranavirritonavir TPVRTV alone or in combination with RTV-boosted saquinavir SQV amprenavir APV or lopinavir LPV plus an optimized background regimen in multiple antiretroviral ARV experienced HIV-1 patients
The primary objective is to determine the safety and pharmacokinetics of
TPVRTV given with an optimized background regimen OBR and TPVRTV given in combination with saquinavir amprenavir or Kaletra and an optimized background regimen OBR
The primary objective is to determine the safety and pharmacokinetics of
TPVRTV given with an optimized background regimen OBR and TPVRTV given in combination with saquinavir amprenavir or Kaletra and an optimized background regimen OBR
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