Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144287
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2005-09-02
Brief Title:
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir TPVr in Patients With Advanced HIV-1 Infection and Limited Treatment Options
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open Label Safety Study of Tipranavir Co-Administered With Low-Dose Ritonavir TVPr in Patients With Advanced HIV-1 Infection and Limited Treatment Options
Status:
COMPLETED
Status Verified Date:
2013-11
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 study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective
Detailed Description:
The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir 500 mg tipranavir200 mg ritonavir BID in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens
The safety assessment will be performed by evaluating
The frequency of treatment-emergent adverse events AEs all serious adverse events SAEs and additional safety laboratory parameters
The occurrence of PI class-specific AEs such as hemorrhage dyslipidemia hepatic events hyperglycemia pancreatitis and rash
The efficacy assessment will be performed by evaluating
The quantity of HIV-1 RNA
The CD4 cell count
Study Hypothesis
The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir 500 mg tipranavir200 mg ritonavir BID in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens
Comparisons
NA
The safety assessment will be performed by evaluating
The frequency of treatment-emergent adverse events AEs all serious adverse events SAEs and additional safety laboratory parameters
The occurrence of PI class-specific AEs such as hemorrhage dyslipidemia hepatic events hyperglycemia pancreatitis and rash
The efficacy assessment will be performed by evaluating
The quantity of HIV-1 RNA
The CD4 cell count
Study Hypothesis
The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir 500 mg tipranavir200 mg ritonavir BID in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens
Comparisons
NA
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