NCT00081588

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 555 (actual)
• Sponsor: Tibotec Pharmaceuticals, Ireland · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria. It is estimated that approximately 150 patients may meet these criteria. Major inclusion and exclusion criteria are listed below. For new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (NRTI), one non-nucleoside reverse transcriptase inhibitor (NNRTI) and a protease inhibitor (PI). At least one primary PI mutation must be present at screening. Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study. All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study. The recruitment of new patients for the TMC114-C215 trial has been fully enrolled. The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study. Two 300mg/100mg Darunavir/Ritonavir tablets twice daily for 144 weeks.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	TMC114	600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

Timeline

• Start date: 2003-11-01
• Primary completion: 2005-09-01
• Completion: 2008-12-01
• First posted: 2004-04-19
• Last updated: 2014-06-20

Locations

64 sites across 13 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Portugal, Spain, United Kingdom