TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
NCT ID: NCT00245739
Last Updated: 2014-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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This program will be conducted as an open-label, non-randomized treatment study. Once treatment with TMC114/r in combination with other antiretrovirals (ARVs) has been initiated (baseline visit), patients will follow the recommended visit schedule based on routine clinical care. No other protease inhibitor combinations other than TMC114/r are to be used in this study, except atazanavir (ATV) and indinavir (IDV) may be allowed. Trial medication will be dispensed every 8 weeks. Treatment with TMC114/r will be continued until treatment-limiting toxicity, loss to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 has become commercially available.
Selected safety and tolerability data, including adverse events will be collected throughout the study. A urine pregnancy test will be repeated at baseline for female patients if more than 4 weeks have passed since the test at screening, and urine pregnancy tests will be performed at all other visits. In addition, data on CD4 count and viral load will be collected over the treatment period according to local standard of care practice, in order to ensure that patients continue to benefit from treatment with TMC114/r. A final/withdrawal visit as well as a post-trial treatment follow-up contact (4 weeks after the final/withdrawal visit) will be performed. Patients will take oral doses of 600 mg of TMC114 twice daily in combination with 100 mg of ritonavir twice daily, in combination with other antiretrovirals.
Conditions
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Interventions
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TMC-114
600/100 mg tablets of TMC114/rtv BID until commercial available to the subject
Eligibility Criteria
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Inclusion Criteria
* has limited or no treatment options due to virological failure or intolerance to multiple antiretroviral regimens
* is at least 3 class experienced and has previously received 2 different protease inhibitor-based regimens
* has a CD4 cell count \<= 200 cells/mm3
* is not achieving adequate virologic suppression on his/her current regimen and is at risk of clinical or immunologic progression.
Exclusion Criteria
* Patient used investigational medication within the last 30 days (except for abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations, and tipranavir)
* Patient suffers from any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or has evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels, or has grade 3 or 4 laboratory abnormalities as defined by National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) grading scheme
* Female patients that are pregnant or breast-feeding, or of childbearing potential without using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity
18 Years
ALL
No
Sponsors
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Tibotec Pharmaceuticals, Ireland
INDUSTRY
Responsible Party
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Principal Investigators
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Tibotec Pharmaceuticals Clinical Trial
Role: STUDY_DIRECTOR
Tibotec Pharmaceutical Limited
Locations
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Anniston, Alabama, United States
Birmingham, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Bakersfield, California, United States
Baldwin Park, California, United States
Beverly Hills, California, United States
Carmichael, California, United States
Fontana, California, United States
Fountain Valley, California, United States
French Camp, California, United States
Glendale, California, United States
Harbor City, California, United States
Hayward, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angles, California, United States
Newport Beach, California, United States
Oakland, California, United States
Palm Springs, California, United States
Palo Alto, California, United States
Panorama City, California, United States
Paramount, California, United States
Richmond, California, United States
Salinas, California, United States
San Diego, California, United States
San Diego, La Jolla, California, United States
San Francisco, California, United States
San Mateo, California, United States
San Rafael, California, United States
Santa Ana, California, United States
Santa Clara, California, United States
Santa Clarita, California, United States
Santa Rosa, California, United States
Stanford, California, United States
Sunnyvale, California, United States
Tarzana, California, United States
Ukiah, California, United States
West Hollywood, California, United States
Woodland Hills, California, United States
Denver, Colorado, United States
Glastonbury, Connecticut, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Norwalk, Connecticut, United States
Norwich, Connecticut, United States
Stanford, Connecticut, United States
Vernon Rockville, Connecticut, United States
Washington D.C., District of Columbia, United States
Boynton Beach, Florida, United States
Brandon, Florida, United States
Fort Lauderdale, Florida, United States
Fort Laudersale, Florida, United States
Fort Myers, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
LaBelle, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
North Miami Beach, Florida, United States
North Palm Beach, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Port Saint Lucie, Florida, United States
Safety Harbor, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Austell, Georgia, United States
Decatur, Georgia, United States
Jesup, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Riverdale, Georgia, United States
Tucker, Georgia, United States
Honolulu, Hawaii, United States
Kahului, Hawaii, United States
Kapaa, Hawaii, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Granite City, Illinois, United States
Joliet, Illinois, United States
Rockford, Illinois, United States
Round Lake Beach, Illinois, United States
Springfield, Illinois, United States
Topeka, Kansas, United States
Henderson, Kentucky, United States
Paducah, Kentucky, United States
New Orleans, Louisiana, United States
Bangor, Maine, United States
Lewiston, Maine, United States
Monmouth, Maine, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Elkton, Maryland, United States
Silver Spring, Maryland, United States
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
Springfield, Massachusetts, United States
Berkley, Michigan, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Marquette, Michigan, United States
Minneapolis, Minnesota, United States
Greenwood, Mississippi, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
East Orange, New Jersey, United States
Galloway, New Jersey, United States
Hackensack, New Jersey, United States
Hamilton, New Jersey, United States
Hoboken, New Jersey, United States
Jersey City, New Jersey, United States
Long Branch, New Jersey, United States
Maplewood, New Jersey, United States
Neptune City, New Jersey, United States
Newark, New Jersey, United States
Perth Amboy, New Jersey, United States
Somers Point, New Jersey, United States
Voorhees Township, New Jersey, United States
West Orange, New Jersey, United States
Westfield, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Briarcliff, New York, United States
Bronxville, New York, United States
Brooklyn, New York, United States
Flushing, New York, United States
Harris, New York, United States
Manhasset, New York, United States
Mount Vernon, New York, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Valhalla, New York, United States
Yonkers, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Huntersville, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Easton, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
West Columbia, South Carolina, United States
Hermitage, Tennessee, United States
Johnson City, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Bryan, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
Lackland City, Texas, United States
Longview, Texas, United States
San Antonio, Texas, United States
Annandale, Virginia, United States
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Hampton, Virginia, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Portsmouth, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Eau Claire, Wisconsin, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Charleroi, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Yvoir, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Moncton, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Whitby, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Rouyn-Noranda, Quebec, Canada
Ste-Foy, Quebec, Canada
Vancouver, , Canada
Vancouver British, , Canada
Prague, , Czechia
Aalborg, , Denmark
Aarhus, , Denmark
Copenhagen, , Denmark
Hvidovre, , Denmark
Odense, , Denmark
Aachen, , Germany
Berlin, , Germany
Bochum, , Germany
Bonn, , Germany
Bremen, , Germany
Chemnitz, , Germany
Cologne, , Germany
Dortmund, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Erlangen, , Germany
Essen, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Giessen, , Germany
Hamburg, , Germany
Hanover, , Germany
Kiel, , Germany
Koblenz, , Germany
Konstanz, , Germany
Kÿln, , Germany
Leipzig, , Germany
Mainz, , Germany
Mannheim, , Germany
Munich, , Germany
München, , Germany
Münster, , Germany
Nuremberg, , Germany
Osnabrück, , Germany
Regensburg, , Germany
Saarbrücken, , Germany
Salzgitter, , Germany
Stuttgart, , Germany
Wuppertal, , Germany
Würzburg, , Germany
Athens, , Greece
Piraeus, , Greece
Thessalonikis, , Greece
Budapest, , Hungary
Luxembourg, , Luxembourg
Ipoh, , Malaysia
Kuala Lumpur, , Malaysia
Pulau Pinang, , Malaysia
Col Tacuba, , Mexico
Guadalajara, , Mexico
Mex Ctity, , Mexico
Mexico City, , Mexico
México, , Mexico
Monterrey Nuevo León, , Mexico
Oaxaca City, , Mexico
Puebla City, , Mexico
Veracruz, , Mexico
Alkmaar, , Netherlands
Amsterdam, , Netherlands
Arnhem, , Netherlands
Eindhoven, , Netherlands
Enschede, , Netherlands
Groningen, , Netherlands
Leiden, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
The Hague, , Netherlands
Tilburg, , Netherlands
Ponce Pr, , Puerto Rico
Rio Piedras Pr, , Puerto Rico
San Juan, , Puerto Rico
Kazan', , Russia
Krasnodar, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk Region, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Tver', , Russia
Volgograd, , Russia
Voronezh, , Russia
Yekaterinburg, , Russia
Ljubljana, , Slovenia
A Coruña, , Spain
Alicante, , Spain
Badajoz, , Spain
Barakaldo Vizcaya S/N, , Spain
Barcelona, , Spain
Bilbao, , Spain
Calella (Barcelona), , Spain
Castellon, , Spain
Cáceres, , Spain
Córdoba, , Spain
Cuenca, , Spain
Donostia Guipuzcoa, , Spain
El Palmar Murcia N/A, , Spain
Elche, , Spain
Figueres, , Spain
Fuenlabrada, , Spain
Gijon Asturias, , Spain
Girona, , Spain
Granada, , Spain
Guadalajara, , Spain
Huelva, , Spain
Huesca, , Spain
Ibiza Town, , Spain
Jérez, , Spain
Las Palmas de Gran Canaria, , Spain
León, , Spain
Lleida, , Spain
Logroño, , Spain
Madrid, , Spain
Mahon, , Spain
Manresa, , Spain
Málaga, , Spain
Murcia, , Spain
Oviedo, , Spain
Palma de Mallorca, , Spain
Palma de Mallorca Illes Balear, , Spain
Pamplona, , Spain
Puerto Real, , Spain
Sabadell, , Spain
Salamanca, , Spain
San Cristóbal de La Laguna, , Spain
Santa Cruz de Tenerife, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Tarragona, , Spain
Terrassa, , Spain
Valencia, , Spain
Valladolid, , Spain
Vic, , Spain
Vigo, , Spain
Villafranca Del Penedes, , Spain
Vitoria-Gasteiz, , Spain
Vizcaya N/A, , Spain
Zamora, , Spain
Zaragoza, , Spain
Gothenburg, , Sweden
Linköping, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Aarau, , Switzerland
Basel, , Switzerland
Bern, , Switzerland
Bruderholz, , Switzerland
Chur, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Lugano, , Switzerland
Sankt Gallen, , Switzerland
Zurich, , Switzerland
Zurich Zh, , Switzerland
Kaohsiung City, , Taiwan
Kaohsiung County, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Caracas, , Venezuela
Countries
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Other Identifiers
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TMC114-C226
Identifier Type: OTHER
Identifier Source: secondary_id
CR006304
Identifier Type: -
Identifier Source: org_study_id
NCT00613483
Identifier Type: -
Identifier Source: nct_alias
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