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
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|ClinicalTrials.gov Identifier: NCT00354627|
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : June 12, 2015
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|Condition or disease||Intervention/treatment||Phase|
|HIV-1||Drug: TMC125||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5178 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Access of TMC125 in Combination With Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects With Limited Treatment Options|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||March 2012|
TMC125 200 mg b.i.d. till commercially available.
200 mg b.i.d. till commercially available.
- The primary objective of TMC125-C214 is to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens and have limited treatment options with currently approved ARVs. [ Time Frame: pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. ]
- The secondary objective of this trial is to gather information on the safety and tolerability aspects of TMC125 in combination with other ARVs. Available efficacy data will also be collected. [ Time Frame: pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354627
|Study Director:||Tibotec Pharmaceuticals Clinical Trial||Tibotec Pharmaceutical Limited|
|Responsible Party:||Tibotec Pharmaceuticals, Ireland|
|Other Study ID Numbers:||
TMC125-C214 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
|First Posted:||July 20, 2006 Key Record Dates|
|Last Update Posted:||June 12, 2015|
|Last Verified:||June 2015|
Early Access Program (EAP)
failing multiple antiretroviral (ARV) regimens
limited to no treatment options
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action