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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
Sponsor: Tibotec Pharmaceuticals, Ireland
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.
Official title: Early Access of TMC125 in Combination With Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects With Limited Treatment Options
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
TMC125
200 mg b.i.d. till commercially available.
Locations (304)
Anniston, Alabama, United States
Birmingham, Alabama, United States
Flagstaff, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
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Arcata, California, United States
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Ukiah, California, United States
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Norwich, Connecticut, United States
Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
LaBelle, Florida, United States
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Joliet, Illinois, United States
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Indianapolis, Indiana, United States
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Henderson, Kentucky, United States
Paducah, Kentucky, United States
New Orleans, Louisiana, United States
Ellsworth, Maine, United States
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