Status:
COMPLETED
The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability aspects of TMC1...
Detailed Description
This is an open label trial with primary objective to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens and have l...
Eligibility Criteria
Inclusion
- Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors \[N\[t\]RTI\], protease inhibitors \[PI\], non-nucleoside reverse transcriptase inhibitors \[NNRTI\])
- Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N\[t\]RTIs) and meet all the other inclusion criteria
- Patient has previously received 2 different PI-based regimens
- Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
- Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
Exclusion
- Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
- Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
- Use of investigational ARVs (with exceptions)
- Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase
- Pregnant or breast-feeding female
- Female patient of childbearing potential not using effective non-hormonal birth control methods
- Patients with specific laboratory abnormalities
- Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
5178 Patients enrolled
Trial Details
Trial ID
NCT00354627
Start Date
January 1 2006
End Date
March 1 2012
Last Update
June 12 2015
Active Locations (259)
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1
Anniston, Alabama, United States
2
Birmingham, Alabama, United States
3
Phoenix, Arizona, United States
4
Tucson, Arizona, United States