TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patient has 3 or more primary protease inhibitor mutations

• documented genotypic evidence of resistance to currently available NNRTIs (non-nucleoside reverse transcriptase inhibitors) by having at least 1 NNRTI resistance-associated mutation

• on a stable antiretroviral therapy for at least 8 weeks

• plasma viral load at screening visit > 5000 HIV-1 RNA copies/mL.

Exclusion Criteria:

• Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)

• Any grade 3 or grade 4 toxicity according to the DAIDS grading scale

• Use of disallowed concurrent therapy

• Any active clinically significant disease