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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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 virus Type 1 (HIV-1) infected participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Enfuvirtide; Etravirine; HIV Protease Inhibitors; Protease Inhibitors; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)