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TMC125 (Phase II Study) in 150 HIV+ Patients with Resistance to NNRTIs and 3 or More Protease Inhibitor Mutations
  This study is currently recruiting patients.
Sponsored by
Tibotec Pharmaceutical
Study Purpose
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 inyour blood when administered twice daily for 48 weeks. 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. 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.
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control, Safety/Efficacy Study
Official Title: A randomized, controlled, partially blinded Phase IIb dose-finding trial of TMC125 in HIV-1 infected subjects with documented genotypicevidence of resistance to currently available NNRTIs and with at least three primary PI mutations.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Expected Total Enrollment: 150
Location and Contact Information
Kathy J Iveson, RN 609 730-7541 kiveson@tibus.jnj.com
California Tower ID Medical Associates, Los Angeles, California, 90048, United States; Not yet recruiting
--Edwin Graham, RN 310-358-2300 Ext. 1203 edwin_graham@towerid.com
David Anderson, MD, Principal Investigator
New Jersey ID Care, Hillsborough, New Jersey, 08844, United States; Recruiting
--Debbie Winters 908-725-2522 dwinters@idcare.com
Ronald Nahass, MD, Principal Investigator
New York Polari Medical Group, New York, New York, 10011, United States; Recruiting
--Daniel Dugin 212-929-2629 dan@polari.net
--Susan Parker 212-929-2629 Ext. 13 susan@polari.net
Howard A Grossman, MD, Principal Investigator
Oklahoma Associates in Medical & Mental Health, Tulsa, Oklahoma, 74137, United States; Recruiting
--Frances Haas, D.O. 918-599-5222 drhaas@aimmh.com
Frances Haas, DO, Principal Investigator
More Information
Study ID Numbers TMC125-C223
Study Start Date April 2004
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