The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs
Early Access of TMC125 in Combination With Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects With Limited Treatment Options
2 other identifiers
interventional
5,178
16 countries
259
Brief Summary
The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected. To be eligible, patients should be failing their current ARV regimen or be on a treatment interruption, should have previously received 2 different protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease inhibitors \[PI\], nucleoside/tide reverse transcriptase inhibitors \[N\[t\]RTIs\] and non-nucleoside reverse transcriptase inhibitors \[NNRTIs\]) or at least 2-class experienced (PIs and N\[t\]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2006
Longer than P75 for phase_3
259 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 18, 2006
CompletedFirst Posted
Study publicly available on registry
July 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 12, 2015
June 1, 2015
6.1 years
July 18, 2006
June 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of TMC125-C214 is to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens and have limited treatment options with currently approved ARVs.
pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country.
Secondary Outcomes (1)
The secondary objective of this trial is to gather information on the safety and tolerability aspects of TMC125 in combination with other ARVs. Available efficacy data will also be collected.
pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country.
Study Arms (1)
TMC125
EXPERIMENTALTMC125 200 mg b.i.d. till commercially available.
Interventions
Eligibility Criteria
You may qualify if:
- Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors \[N\[t\]RTI\], protease inhibitors \[PI\], non-nucleoside reverse transcriptase inhibitors \[NNRTI\])
- Patient has previously received 2 different PI-based regimens
- Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
- Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.
You may not qualify if:
- Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
- Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
- Use of investigational ARVs (with exceptions)
- Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the Screening Phase
- Pregnant or breast-feeding female
- Female patient of childbearing potential not using effective non-hormonal birth control methods
- Patients with specific laboratory abnormalities
- Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (259)
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Arcata, California, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Fontana, California, United States
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Fountain Valley, California, United States
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Garden Grove, California, United States
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Harbor City, California, United States
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Hayward, California, United States
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Loma Linda, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Oakland, California, United States
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Palm Springs, California, United States
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Panorama City, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Mateo, California, United States
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San Rafael, California, United States
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Santa Ana, California, United States
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Santa Clara, California, United States
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Santa Clarita, California, United States
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Santa Rosa, California, United States
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Stanford, California, United States
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Tarzana, California, United States
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Ukiah, California, United States
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Woodland Hills, California, United States
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Denver, Colorado, United States
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Wheat Ridge, Colorado, United States
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Glastonbury, Connecticut, United States
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New Haven, Connecticut, United States
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Norwalk, Connecticut, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Laudersale, Florida, United States
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Hollywood, Florida, United States
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LaBelle, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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North Palm Beach, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Plantation, Florida, United States
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Port Saint Lucie, Florida, United States
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Safety Harbor, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Tarpon Springs, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Jesup, Georgia, United States
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Macon, Georgia, United States
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Riverdale, Georgia, United States
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Savannah, Georgia, United States
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Tucker, Georgia, United States
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Honolulu, Hawaii, United States
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Aurora, Illinois, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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Henderson, Kentucky, United States
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Paducah, Kentucky, United States
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New Orleans, Louisiana, United States
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Ellsworth, Maine, United States
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Portland, Maine, United States
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Baltimore, Maryland, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Grosse Pointe Woods, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Rochester, New Hampshire, United States
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Englewood, New Jersey, United States
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Hackensack, New Jersey, United States
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Long Branch, New Jersey, United States
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Neptune City, New Jersey, United States
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Newark, New Jersey, United States
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Perth Amboy, New Jersey, United States
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Somers Point, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Westfield, New Jersey, United States
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Santa Fe, New Mexico, United States
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Briarcliff, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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East Meadow, New York, United States
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Elmira, New York, United States
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Flushing, New York, United States
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Kingston, New York, United States
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Manhasset, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Gastonia, North Carolina, United States
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Huntersville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Johnson City, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, United States
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Annandale, Virginia, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Hampton, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Olympia, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Yakima, Washington, United States
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Charleston, West Virginia, United States
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La Crosse, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Antwerp, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Whitby, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Aarhus, Denmark
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Copenhagen, Denmark
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Hvidovre, Denmark
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Odense, Denmark
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Aachen, Germany
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Berlin, Germany
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Bochum, Germany
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Bonn, Germany
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Cologne, Germany
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Düsseldorf, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Hanover, Germany
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Mainz, Germany
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Mannheim, Germany
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Munich, Germany
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München, Germany
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Münster, Germany
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Osnabrück, Germany
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Stuttgart, Germany
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Würzburg, Germany
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Athens, Greece
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Pátrai, Greece
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Thessalonikis, Greece
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Luxembourg, Luxembourg
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Bosques Del Nogalar San Nicola, Mexico
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Chihuahua City, Mexico
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Col Tacuba, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Monterrey Nuevo León, Mexico
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Puebla City, Mexico
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Tijuana, Mexico
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Amsterdam-Zuidoost, Netherlands
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Arnhem, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Utrecht, Netherlands
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San Juan, Puerto Rico
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Moscow, Russia
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Saint Petersburg, Russia
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Volgograd, Russia
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Kyungki, South Korea
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Pusan, South Korea
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Seoul, South Korea
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Alicante, Spain
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Barcelona, Spain
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Bilbao, Spain
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Cadiz, Spain
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Cuenca, Spain
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Elche, Spain
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Granada, Spain
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Granollers, Spain
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Logroño, Spain
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Madrid, Spain
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Málaga, Spain
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Murcia, Spain
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Oviedo, Spain
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Sabadell, Spain
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San Cristóbal de La Laguna, Spain
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Santa Cruz de Tenerife, Spain
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Santiago de Compostela (La Cor, Spain
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Seville, Spain
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Terrassa, Spain
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Valencia, Spain
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Vigo, Spain
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Vitoria-Gasteiz, Spain
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Gothenburg, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Kaohsiung City, Taiwan
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Taipei, Taiwan
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Ankara, Turkey (Türkiye)
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2006
First Posted
July 20, 2006
Study Start
January 1, 2006
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
June 12, 2015
Record last verified: 2015-06