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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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 TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected. To be eligible, patients should be failing their current ARV regimen or be on a treatment interruption, should have previously received 2 different protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease inhibitors [PI], nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Etravirine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.