Status:
COMPLETED
An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to eval...
Detailed Description
The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet spe...
Eligibility Criteria
Inclusion
- Previous participation in the TMC114-C202 or TMC114-C213 trials
- Significant virologic failure during participation in the above trials
- Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
- Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
- Patient has given informed consent
Exclusion
- Use of disallowed concomitant therapy
- Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
- Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
- Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol
- Patient withdrawing consent from TMC114-C202 or TMC114-C213
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
555 Patients enrolled
Trial Details
Trial ID
NCT00081588
Start Date
November 1 2003
End Date
December 1 2008
Last Update
June 20 2014
Active Locations (64)
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1
Birmingham, Alabama, United States
2
Beverly Hills, California, United States
3
La Jolla, California, United States
4
Long Beach, California, United States