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TMC-125 + TMC-114 Combination Study
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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 to No Treatment Options.
This study is currently recruiting patients.
Verified by Tibotec Pharmaceuticals Limited, Ireland November 2005
Study start: October 2005
Eligibility
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
This is a Phase III, randomized, double-blind, placebo-controlled trial to evaluate the long-term efficacy, tolerability, and safety of TMC125 as part of an antiretroviral therapy (ART) regimen containing TMC114/ritonavir (RTV) and an investigator-selected optimized background (OBR) in treatment-experienced HIV-1 infected patients. TMC125 is a non-nucleoside reverse transcriptase inhibitor (NNRTI). TMC114 is a protease inhibitor (PI). In this trial, TMC114 will be given with a low dose of ritonavir (RTV), a protease inhibitor commonly used with other, full dose protease inhibitors to improve activity. Additional assessments to be evaluated in this trial include: changes in the HIV-1 genotype, drug susceptibility, and the population pharmacokinetics of TMC125. A pharmacokinetic substudy will be performed at selected sites. Health-related quality of life will be assessed for patients receiving an antiretroviral therapy containing either TMC125 or placebo. Safety and tolerability will be documented throughout the trial. Six hundred HIV-1 infected patients on a stable but virologically failing regimen will be included in the trial. Patients should have at least 1 documented non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation (either at screening or from historical genotype reports), an HIV-1 plasma viral load > 5000 RNA copies/mL at screening, and at least 3 documented primary protease inhibitor (PI) mutations. Patients will be randomized in a 1:1 ratio to either TMC125 (200 mg twice daily) or to matching placebo; both in combination with TMC114/RTV (600/100 mg twice daily) and an investigator selected OBR of at least 2 antiretrovirals (ARVs), consisting of nucleoside reverse transcriptase inhibitor(s) (NRTI[s]) with or without enfuvirtide. The trial will involve a screening period of up to 6 weeks, a 48-week treatment period, and a 4 week follow-up period.
Patients will take 200 mg oral doses of TMC125 tablets or placebo tablets, twice daily (administered as 2 tablets twice daily, with food) in combination with 600 mg oral doses of TMC114 tablets and 100 mg oral doses of ritonavir (administered as 2 tablets of TMC114 and 1 capsule of ritonavir twice daily, with food). The treatment period is 48 weeks.
For more information please see the link below or email
info@veritasmedicine.com
ADDITIONAL SITES ARE EXPECTED
Arizona
Phoenix, Arizona, 85006, United States; Recruiting
California
Palm Springs, California, 92262, United States; Recruiting
District of Columbia
Washington, District of Columbia, 20009, United States; Recruiting
TMC125-C206: 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 to No Treatment Options.
Location and Contact Information
For more information please see the link below or email info@veritasmedicine.com
Arkansas
Little Rock, Arkansas, 72207, United States; Recruiting
District of Columbia
Washington, District of Columbia, 20036, United States; Recruiting
Georgia
Macon, Georgia, 31201, United States; Recruiting
New Mexico
Santa Fe, New Mexico, 87501, United States; Not yet recruiting
North Carolina
Huntersville, North Carolina, 28078, United States; Recruiting
Texas
Longview, Texas, 75602, United States; Recruiting
Study chairs or principal investigators:
Tibotec Pharmaceuticals Limited, Ireland Clinical Trial, Study Director,
Tibotec Pharmaceuticals Limited, Ireland
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