TMC125-C223: TMC125 in HIV-1 Infected Subjects

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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 for 48 weeks.

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

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Etravirine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.