Clinical Trials


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.

This study has been approved for marketing
Tibotec Pharmaceuticals, Ireland

Information provided by (Responsible Party)
Tibotec Pharmaceuticals, Ireland Identifier

First received: October 27, 2005
Last updated: April 10, 2014
Last Verified: April 2014
History of Changes


The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals

Condition Intervention
HIV Infections

Drug : TMC-114

Study Type: Expanded Access   What is Expanded Access?
Official Title: Early Access of TMC114 in Combination With Low-dose Ritonavir (TMC/r)) and Other Antiretrovirals (ARVs) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to no Treatment Options.

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Detailed Description:

This is a program to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients, who have failed multiple antiretroviral (ARV) regimens and who are ineligible for participation in any other Tibotec-sponsored HIV trial. Patients need to be at least 3 class experienced (PIs, NRTIs, NtRTIs, NNRTIs or FI), to have previously received 2 different protease inhibitor-based regimens and to not be virologically suppressed on their current regimen. Patients eligible for any other Tibotec sponsored HIV trial but located more than 100 kilometers away from a study site, will be considered eligible for this early access program.
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.



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria:

  • Patient with documented HIV-1 infection
  • 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 has primary HIV-1 infection (unless documented resistance to all currently approved protease inhibitors participated or is currently participating in a trial with TMC114
  • 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00245739


United States, Alabama
Anniston, Alabama, United States
Birmingham, Alabama, United States
United States, Arizona
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
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, La Jolla, California, United States
San Diego, 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
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
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
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
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 Beach, Florida, United States
Miami, Florida, United States
N Miami Beach, Florida, United States
North Palm Beach, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Port St 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
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
Austell, Georgia, United States
Decatur, Georgia, United States
Jessup, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Riverdale, Georgia, United States
Tucker, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
Kahului, Hawaii, United States
Kapaa, Hawaii, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
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
United States, Kansas
Topeka, Kansas, United States
United States, Kentucky
Henderson, Kentucky, United States
Paducah, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Maine
Bangor, Maine, United States
Lewiston, Maine, United States
Monmouth, Maine, United States
Portland, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Elkton, Maryland, United States
Silver Spring, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
Springfield, Massachusetts, United States
United States, Michigan
Berkley, Michigan, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Marquette, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Mississippi
Greenwood, Mississippi, United States
United States, Missouri
Columbia, Missouri, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
St. Louis, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
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, New Jersey, United States
Newark, New Jersey, United States
Perth Amboy, New Jersey, United States
Somers Point, New Jersey, United States
Voorhees, New Jersey, United States
West Orange, New Jersey, United States
Westfield, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Albany, New York, United States
Briarcliff, New York, United States
Bronxville, New York, United States
Bronx, New York, United States
Brooklyn, New York, United States
Flushing, New York, United States
Harris, New York, United States
Manhasset, New York, United States
Mt. Vernon, New York, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Valhalla, New York, United States
Yonkers, New York, United States
United States, North Carolina
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
Winston-Salem, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
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
United States, Rhode Island
Providence, Rhode Island, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
West Columbia, South Carolina, United States
United States, Tennessee
Hermitage, Tennessee, United States
Johnson City, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
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, Texas, United States
Longview, Texas, United States
San Antonio, Texas, United States
United States, Virginia
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
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Eau Claire, Wisconsin, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Antwerpen, Belgium
Brugge, Belgium
Brussels, Belgium
Bruxelles, Belgium
Charleroi, Belgium
Gent, 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 British, Canada
Vancouver, Canada
Czech Republic
Prague, Czech Republic
Aalborg, Denmark
Aarhus, Denmark
Copenhagen, Denmark
Hvidovre N/A, Denmark
Odense N/A, Denmark
Aachen, Germany
Berlin, Germany
Bochum, Germany
Bonn, Germany
Bremen, Germany
Chemnitz, Germany
Dortmund, Germany
Dresden, Germany
Duesseldorf, Germany
Düsseldorf, Germany
Erlangen, Germany
Essen, Germany
Frankfurt, Germany
Freiburg, Germany
Gießen, Germany
Hamburg, Germany
Hannover, Germany
Kiel, Germany
Koblenz, Germany
Konstanz, Germany
Köln, Germany
Kÿln, Germany
Leipzig, Germany
Mainz, Germany
Mannheim, Germany
Munich, Germany
München, Germany
Münster, Germany
Nürnberg, 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
Ciudad De Mexico, Mexico
Col Tacuba, Mexico
Guadalajara, Mexico
Mex Ctity, Mexico
Mexico, Mexico
Monterrey Nuevo León, Mexico
Oaxaca, Mexico
Puebla, Mexico
Veracruz, Mexico
Alkmaar, Netherlands
Amsterdam, Netherlands
Arnhem, Netherlands
Den Haag, Netherlands
Eindhoven, Netherlands
Enschede, Netherlands
Groningen, Netherlands
Leiden, Netherlands
Maastricht, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Tilburg, Netherlands
Puerto Rico
Ponce Pr, Puerto Rico
Rio Piedras Pr, Puerto Rico
San Juan, Puerto Rico
Russian Federation
Ekaterinbourg, Russian Federation
Kazan, Russian Federation
Krasnodar, Russian Federation
Moscow N/A, Russian Federation
Moscow, Russian Federation
Nizhny Novgorod, Russian Federation
Novosibirsk Region, Russian Federation
Rostov-Na-Donu, Russian Federation
Saint-Petersburg, Russian Federation
Smolensk, Russian Federation
St Petersburg, Russian Federation
Tver, Russian Federation
Volgograd, Russian Federation
Voronezh, Russian Federation
Ljubljana, Slovenia
Alicante, Spain
Badajoz, Spain
Barakaldo Vizcaya S/N, Spain
Barcelona N/A, Spain
Barcelona, Spain
Bilbao, Spain
Caceres N/A, Spain
Calella (Barcelona), Spain
Castellon, Spain
Cordoba, 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 N/A, Spain
Huelva, Spain
Huesca, Spain
Ibiza, Spain
Jérez, Spain
La Coruna, Spain
La Laguna, Spain
Las Palmas De Gran Canaria, Spain
Leon N/A, Spain
Lleida, Spain
Logrono, Spain
Madrid N/A, Spain
Madrid, Spain
Mahon Menorca, Spain
Malaga N/A, Spain
Malaga, Spain
Manresa, Spain
Murcia N/A, Spain
Murcia, Spain
Oviedo, Spain
Palma De Mallorca Illes Balear, Spain
Palma De Mallorca, Spain
Pamplona N/A, Spain
Puerto Real, Spain
Sabadell, Spain
Salamanca, Spain
Santander N/A, Spain
Santiago De Compostela, Spain
Sevilla N/A, Spain
Sevilla, Spain
Sta Cruz De Tenerife, Spain
Tarragona N/A, Spain
Tarragona, Spain
Terrassa, Spain
Valencia N/A, Spain
Valencia, Spain
Valladolid, Spain
Vic, Spain
Vigo, Spain
Villafranca Del Penedes, Spain
Vitoria-Gasteiz, Spain
Vizcaya N/A, Spain
Zamora N/A, Spain
Zaragoza, Spain
Göteborg N/A, Sweden
Göteborg, Sweden
Linköping, Sweden
Malmö, Sweden
Stockholm, Sweden
Uppsala, Sweden
Aarau, Switzerland
Basel, Switzerland
Bern, Switzerland
Bruderholz, Switzerland
Chur, Switzerland
Genève, Switzerland
Lausanne, Switzerland
Lugano N/A, Switzerland
St Gallen, Switzerland
Zurich N/A, Switzerland
Zurich Zh, Switzerland
Kaohsiung County, Taiwan
Kaohsiung, Taiwan
Taipei, Taiwan
Tao-Yuan, Taiwan
Bangkok, Thailand
Ankara, Turkey
Istanbul, Turkey
Caracas, Venezuela

Sponsors and Collaborators

Tibotec Pharmaceuticals, Ireland


Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
More Information

More Information

Responsible Party: Tibotec Pharmaceuticals, Ireland Identifier: NCT00245739   History of Changes  
Other Study ID Numbers: CR006304  
Study First Received: October 27, 2005  
Last Updated: April 10, 2014  

Keywords provided by Tibotec Pharmaceuticals, Ireland:

HIV infections
Early access
Highly antiretroviral treatment experienced patients
Anti-retroviral agents

Additional relevant MeSH terms:
HIV Infections
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