Status:
COMPLETED
TMC125-C223: TMC125 in HIV-1 Infected Subjects
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily fo...
Detailed Description
TMC125 will be given in addition to a combination of anti-HIV drugs that have been selected specifically for you by your doctor. There are three treatment groups in the study. One group will be given ...
Eligibility Criteria
Inclusion
- HIV-1 plasma viral load at screening \>1000 copies/ml
- Documented genotypic evidence of resistance to currently available NNRTIs
- Previous NRTI experience for at least 3 months
- 3 primary PI mutations at screening
Exclusion
- Chronic HBV and/or HCV with elevated liver function tests \> 3x upper normal limits
- Any grade 3 or 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevation)
- Previous permanent discontinuation of any NNRTI due to cutaneous events.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00081978
Start Date
March 1 2004
End Date
October 1 2005
Last Update
April 28 2010
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