Status:
COMPLETED
An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optim...
Detailed Description
This is a Phase III open-label, roll-over trial to evaluate the long term tolerability, safety, antiviral and immunological effect of TMC125 as part of an individually optimized antiretroviral therapy...
Eligibility Criteria
Inclusion
- Patient was previously randomized in a DUET (TMC125-C206 or TMC125-C216) trial and completed at least 24 weeks of treatment
- Patient was virologically failing in a DUET trial.
Exclusion
- Use of disallowed concomitant therapy
- Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table
- Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials because of any of the mandatory withdrawal criteria of that trial.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT00359021
Start Date
June 1 2006
End Date
January 1 2012
Last Update
May 16 2014
Active Locations (72)
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Phoenix, Arizona, United States
2
Little Rock, Arkansas, United States
3
Beverly Hills, California, United States
4
Long Beach, California, United States