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.

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.

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

Study Overview

• Status: Approved for marketing
• Conditions: HIV Infections
• Intervention / Treatment: Drug: TMC-114

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.

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
  • Brugge, Belgium
  • Brussels, Belgium
  • Bruxelles, Belgium
  • Charleroi, Belgium
  • Gent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Yvoir, Belgium
• Canada
  • Vancouver, Canada
  • Vancouver British, Canada
  • Alberta
    • Calgary, Alberta, Canada
    • Edmonton, Alberta, Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
  • Ontario
    • Hamilton, Ontario, Canada
    • Kingston, Ontario, Canada
    • London, Ontario, Canada
    • Ottawa, Ontario, Canada
    • Toronto, Ontario, Canada
    • Whitby, Ontario, Canada
    • Windsor, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
    • Rouyn-Noranda, Quebec, Canada
    • Ste-Foy, Quebec, Canada
• Czech Republic
  • Prague, Czech Republic
• Denmark
  • Aalborg, Denmark
  • Aarhus, Denmark
  • Copenhagen, Denmark
  • Hvidovre N/A, Denmark
  • Odense N/A, Denmark
• Germany
  • 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
• Greece
  • Athens, Greece
  • Piraeus, Greece
  • Thessalonikis, Greece
• Hungary
  • Budapest, Hungary
• Luxembourg
  • Luxembourg, Luxembourg
• Malaysia
  • Ipoh, Malaysia
  • Kuala Lumpur, Malaysia
  • Pulau Pinang, Malaysia
• Mexico
  • Ciudad De Mexico, Mexico
  • Col Tacuba, Mexico
  • Guadalajara, Mexico
  • Mex Ctity, Mexico
  • Mexico, Mexico
  • Monterrey Nuevo León, Mexico
  • Oaxaca, Mexico
  • Puebla, Mexico
  • Veracruz, Mexico
• Netherlands
  • 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, Russian Federation
  • Moscow N/A, 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
• Slovenia
  • Ljubljana, Slovenia
• Spain
  • Alicante, Spain
  • Badajoz, Spain
  • Barakaldo Vizcaya S/N, Spain
  • Barcelona, Spain
  • Barcelona N/A, 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, Spain
  • Huelva N/A, 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, Spain
  • Madrid N/A, Spain
  • Mahon Menorca, Spain
  • Malaga, Spain
  • Malaga N/A, Spain
  • Manresa, Spain
  • Murcia, Spain
  • Murcia N/A, Spain
  • Oviedo, Spain
  • Palma De Mallorca, Spain
  • Palma De Mallorca Illes Balear, Spain
  • Pamplona N/A, Spain
  • Puerto Real, Spain
  • Sabadell, Spain
  • Salamanca, Spain
  • Santander N/A, Spain
  • Santiago De Compostela, Spain
  • Sevilla, Spain
  • Sevilla N/A, Spain
  • Sta Cruz De Tenerife, Spain
  • Tarragona, Spain
  • Tarragona N/A, Spain
  • Terrassa, Spain
  • Valencia, Spain
  • Valencia N/A, Spain
  • Valladolid, Spain
  • Vic, Spain
  • Vigo, Spain
  • Villafranca Del Penedes, Spain
  • Vitoria-Gasteiz, Spain
  • Vizcaya N/A, Spain
  • Zamora N/A, Spain
  • Zaragoza, Spain
• Sweden
  • Göteborg, Sweden
  • Göteborg N/A, Sweden
  • Linköping, Sweden
  • Malmö, Sweden
  • Stockholm, Sweden
  • Uppsala, Sweden
• Switzerland
  • 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
• Taiwan
  • Kaohsiung, Taiwan
  • Kaohsiung County, Taiwan
  • Taipei, Taiwan
  • Tao-Yuan, Taiwan
• Thailand
  • Bangkok, Thailand
• Turkey
  • Ankara, Turkey
  • Istanbul, Turkey
• United States
  • Alabama
    • Anniston, Alabama, United States
    • Birmingham, Alabama, United States
  • Arizona
    • Mesa, Arizona, United States
    • Phoenix, Arizona, United States
    • Tucson, Arizona, 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, 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
  • Colorado
    • Denver, Colorado, 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
  • District of Columbia
    • Washington, District of Columbia, 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, Florida, United States
    • Miami Beach, 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
  • 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
  • Hawaii
    • Honolulu, Hawaii, United States
    • Kahului, Hawaii, United States
    • Kapaa, Hawaii, United States
  • Idaho
    • Boise, Idaho, 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
  • Kansas
    • Topeka, Kansas, United States
  • Kentucky
    • Henderson, Kentucky, United States
    • Paducah, Kentucky, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • Maine
    • Bangor, Maine, United States
    • Lewiston, Maine, United States
    • Monmouth, Maine, United States
    • Portland, Maine, United States
  • Maryland
    • Baltimore, Maryland, United States
    • Bethesda, Maryland, United States
    • Elkton, Maryland, United States
    • Silver Spring, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
    • Cambridge, Massachusetts, United States
    • Springfield, Massachusetts, United States
  • Michigan
    • Berkley, Michigan, United States
    • Detroit, Michigan, United States
    • Grosse Pointe Woods, Michigan, United States
    • Marquette, Michigan, United States
  • Minnesota
    • Minneapolis, Minnesota, United States
  • Mississippi
    • Greenwood, Mississippi, United States
  • Missouri
    • Columbia, Missouri, United States
    • Kansas City, Missouri, United States
    • Saint Louis, Missouri, United States
    • St. Louis, Missouri, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • New Hampshire
    • Lebanon, New Hampshire, 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
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • Albany, New York, United States
    • Briarcliff, New York, United States
    • Bronx, 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
    • 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
  • 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
  • Ohio
    • Akron, Ohio, United States
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
    • Columbus, Ohio, United States
    • Dayton, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Portland, Oregon, 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
  • Rhode Island
    • Providence, Rhode Island, United States
  • South Carolina
    • Charleston, South Carolina, United States
    • Columbia, South Carolina, United States
    • West Columbia, South Carolina, United States
  • Tennessee
    • Hermitage, Tennessee, United States
    • Johnson City, Tennessee, United States
    • Knoxville, Tennessee, United States
    • Memphis, Tennessee, United States
    • Nashville, Tennessee, 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
  • 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
  • Washington
    • Seattle, Washington, United States
  • Wisconsin
    • Eau Claire, Wisconsin, United States
    • Madison, Wisconsin, United States
    • Milwaukee, Wisconsin, United States
• Venezuela
  • Caracas, Venezuela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Tibotec Pharmaceuticals, Ireland

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: October 27, 2005
• First Submitted That Met QC Criteria: October 27, 2005
• First Posted (Estimate): October 28, 2005

Study Record Updates

• Last Update Posted (Estimate): April 11, 2014
• Last Update Submitted That Met QC Criteria: April 10, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: HIV-1; HIV infections; TMC114; Early access; Highly antiretroviral treatment experienced patients; Anti-retroviral agents
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Darunavir
• Other Study ID Numbers: CR006304; TMC114-C226 (Other Identifier: Tibotec Pharmaceuticals, Ireland)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No