An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 evaluate the immunological effect over time.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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