Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034866
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2002-05-02
Brief Title:
Dose Ranging Trial of TipranavirRitonavir in Treatment-Experienced HIV Infected Individuals
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Double-Blind Randomized Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir TPVRTV in Multiple Antiretroviral Drug-Experienced Subjects
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir when taken with a standard approved anti-HIV drug therapy is most effective and safe Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1
Detailed Description:
This study will be conducted in HIV multiple ARV medication experienced patients All patients must have received treatment from each of three ARV classes NRTIs NNRTIs and PIs have received at least two PI-based ARV regimens may include the current regimen with a viral load greater than or equal to 1000 copiesmL at the time of study entry The two separate PI-based regimens must each have been taken for at least 3 months At least one resistance-conferring PI-mutation from a pre-established panel must be present Baseline genotypic screening will be performed and will be used in conjunction with ARV medication history to determine new background therapy for each individual subject to use
Following genotypic screening at baseline qualifying subjects will be randomized to one of three blinded treatment regimens Subjects will discontinue their current protease inhibitor and initiate TPVRTV for 2 weeks of functional monotherapy Thereafter the background ARV medications will be optimized and subjects will remain on blinded TPVRTV plus optimized background therapy for the duration of the trial Trial duration ranges between 12-32 weeks depending on when the subject is entered into the trial and the interim analyses for determination of optimized TPVRTV regimen is completed On determination of the optimal TPVRTV dose subjects may opt to continue open-label treatment
Following genotypic screening at baseline qualifying subjects will be randomized to one of three blinded treatment regimens Subjects will discontinue their current protease inhibitor and initiate TPVRTV for 2 weeks of functional monotherapy Thereafter the background ARV medications will be optimized and subjects will remain on blinded TPVRTV plus optimized background therapy for the duration of the trial Trial duration ranges between 12-32 weeks depending on when the subject is entered into the trial and the interim analyses for determination of optimized TPVRTV regimen is completed On determination of the optimal TPVRTV dose subjects may opt to continue open-label treatment
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