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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
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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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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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New Brunswick
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Moncton, New Brunswick, Canada
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Ontario
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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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Quebec
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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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Koblenz, 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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León, Mexico
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Mexico City, Mexico
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Monterrey Nuevo León, Mexico
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Oaxaca City, Mexico
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Puebla City, Mexico
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Tabasco, Mexico
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Tijuana, Mexico
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Veracruz, 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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Eindhoven, 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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Kazan', Russia
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Moscow, Russia
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Oryol, Russia
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Saint Petersburg, Russia
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Smolensk, 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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A Coruña, Spain
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Alicante, Spain
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Barakaldo Vizcaya, 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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Córdoba, Spain
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Donostia Guipuzcoa, 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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Murcia, Spain
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Málaga, Spain
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Oviedo, Spain
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Palma de Mallorca, Spain
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Pamplona, 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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Zaragoza, Spain
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Gothenburg, Sweden
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Malmö, Sweden
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Stockholm, Sweden
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Ankara, Turkey (Türkiye)
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Alabama
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Arizona
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Flagstaff, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Arkansas
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Little Rock, Arkansas, United States
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California
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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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Baldwin Park, California, United States
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Bellflower, 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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Fremont, California, United States
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Garden Grove, California, United States
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Glendale, 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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Palo Alto, California, United States
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Panorama City, California, United States
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Pasadena, California, United States
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Pico Rivera, California, United States
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Richmond, California, United States
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Sacramento, California, United States
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San Bernardino, 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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Ventura, California, United States
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Woodland Hills, California, United States
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Colorado
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Denver, Colorado, United States
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Wheat Ridge, Colorado, United States
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Connecticut
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Glastonbury, Connecticut, United States
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Hartford, 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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District of Columbia
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Washington D.C., District of Columbia, United States
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Florida
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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, 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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Miami Beach, 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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Oakland Park, 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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Weston, Florida, United States
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Winter Park, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Decatur, 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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Hawaii
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Honolulu, Hawaii, United States
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Idaho
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Boise, Idaho, United States
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Illinois
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Aurora, Illinois, United States
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Chicago, Illinois, United States
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Joliet, Illinois, United States
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Maywood, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Iowa
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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Kentucky
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Henderson, Kentucky, United States
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Paducah, Kentucky, United States
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Louisiana
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New Orleans, Louisiana, United States
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Maine
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Ellsworth, Maine, United States
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Portland, Maine, United States
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Maryland
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Baltimore, Maryland, United States
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Greenbelt, Maryland, United States
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Silver Spring, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Michigan
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Ann Arbor, Michigan, United States
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Berkley, 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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Lansing, Michigan, United States
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Minnesota
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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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Missouri
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Nebraska
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Lincoln, Nebraska, United States
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Nevada
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Las Vegas, Nevada, United States
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New Hampshire
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Rochester, New Hampshire, United States
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New Jersey
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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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Union, 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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New Mexico
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Santa Fe, New Mexico, United States
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New York
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Albany, New York, United States
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Briarcliff Manor, 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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Mount Vernon, 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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North Carolina
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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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Ohio
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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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Oregon
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Portland, Oregon, United States
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Pennsylvania
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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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Rhode Island
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Providence, Rhode Island, United States
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South Carolina
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Tennessee
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Johnson City, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Austin, Texas, United States
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Bellaire, 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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Virginia
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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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Washington
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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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West Virginia
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Charleston, West Virginia, United States
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Wisconsin
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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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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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])
- Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: TMC125
TMC125 200 mg b.i.d.
till commercially available.
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200 mg b.i.d.
till commercially available.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country.
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pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country.
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
Time Frame: pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country.
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pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country.
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Tibotec Pharmaceuticals Clinical Trial, Tibotec Pharmaceutical Limited
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion
Primary Completion
Study Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CR002743
- TMC125-C214 (Other Identifier: Tibotec Pharmaceuticals, Ireland)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.