NCT00081978

TMC125-C223: TMC125 in HIV-1 Infected Subjects

A Randomized, Controlled, Partially Blinded Phase IIb Dose-Finding Trial of TMC125 in HIV-1 Infected Subjects With Documented Genotypic Evidence of Resistance to Currently Available NNRTIs and With at Least Three Primary PI Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Tibotec Pharmaceuticals, Ireland · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TMC125 will be given in addition to a combination of anti-HIV drugs that have been selected specifically for you by your doctor. There are three treatment groups in the study. One group will be given a dosage of TMC125, 400 mg twice daily. Another will be given 800 mg twice daily. The third group, a control arm, will not receive TMC125 (formulation TF035). The safety, tolerability and pharmacokinetics (determinations of the concentration of drug in your blood and its evolution over time) of TMC125 will also be evaluated in this study. Patients who have known resistance to NNRTIs and 3 or more protease inhibitor (PI) mutations may be eligible to participate. One-hundred-fifty (150) patients will be enrolled into this study. TMC125, 400mg twice daily for 48 weeks; TMC125, 800mg twice daily for 48 weeks.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	TMC125

Timeline

• Start date: 2004-03-01
• Completion: 2005-10-01
• First posted: 2004-04-30
• Last updated: 2010-04-28