About The Study
The purpose of this study is to provide early access to TMC125 for HIV-1 infected patients who have been on multiple failing antiretroviral (ARV) regimens and have limited treatment options with currently approved ARVs. 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.
All participants will receive TMC125 in the form of two 100 mg tablets to be taken orally following a meal every 12 hours. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications. Study treatment will be continued until virologic failure, treatment-limiting toxicity, patient lost to follow-up, withdrawal, or pregnancy.
TMC125 will be provided via the expanded access program until discontinuation of TMC125 development or when TMC125 becomes commercially available in Canada.
TMC125 is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by Tibotec.
This trial is also listed on Clinicaltrials.gov
Update:This treatment has now been approved for sale to the public.
- 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
- 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