Status:
APPROVED_FOR_MARKETING
TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) re...
Detailed Description
This is a program to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients, who have failed multiple antiretroviral (ARV) regimens and who are ineligible for participation ...
Eligibility Criteria
Inclusion
- Patient with documented HIV-1 infection
- has limited or no treatment options due to virological failure or intolerance to multiple antiretroviral regimens
- is at least 3 class experienced and has previously received 2 different protease inhibitor-based regimens
- has a CD4 cell count \<= 200 cells/mm3
- is not achieving adequate virologic suppression on his/her current regimen and is at risk of clinical or immunologic progression.
Exclusion
- Patient has primary HIV-1 infection (unless documented resistance to all currently approved protease inhibitors participated or is currently participating in a trial with TMC114
- Patient used investigational medication within the last 30 days (except for abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations, and tipranavir)
- Patient suffers from any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or has evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels, or has grade 3 or 4 laboratory abnormalities as defined by National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) grading scheme
- Female patients that are pregnant or breast-feeding, or of childbearing potential without using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00245739
Last Update
April 11 2014
Active Locations (394)
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
3
Mesa, Arizona, United States
4
Phoenix, Arizona, United States