Status:
COMPLETED
A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Human Immunodeficiency Virus Type 1
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency ...
Detailed Description
This is a Phase II, open-label (all people know the identity of the intervention), roll-over study (participants may go ahead and participate in another clinical study). Participants who were randomiz...
Eligibility Criteria
Inclusion
- Participants who were previously randomized to an etravirine (ETR) treatment arm and have completed at least 48 weeks of treatment with ETR
- Participants who will be able to comply with the protocol requirements
- Participants general medical condition should not interfere with the assessments and the completion of the study
Exclusion
- Use of disallowed concomitant therapy unless a prior exemption had been granted
- Participant with any treatment-emergent condition or exacerbation of underlying condition during original Phase II study
- Agrees to protocol-defined use of effective contraception
- Participant with a grade 3 elevation of amylase and/or lipase except for isolated grade 3 increases of amylase with lipase in normal range and no history of pancreatitis
- Participant with any grade 4 toxicity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table; with the exception of grade 4 elevations of triglycerides or glucose asymptomatic or under non-fasting conditions; grade 4 elevation of glucose in participants with pre-existing diabetes
- Participants with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio \[INR\] more than 1.5 or albumin less than 30g/l or bilirubin more than 2.5 x upper limit of normal)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00128830
Start Date
June 1 2005
End Date
August 1 2008
Last Update
June 20 2013
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