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

June 2, 2026 updated by: Tibotec Pharmaceuticals, Ireland

Early Access of TMC125 in Combination With Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects With Limited Treatment Options

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

This is an open label trial with primary objective 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. 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. Patients should be at least 3-class experienced or 2-class experienced with primary non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. They should also have previously received 2 different protease inhibitor-based regimens (low-dose ritonavir is not counted as a protease inhibitor (PI) regimen), be on a treatment interruption or not be virologically suppressed on their current regimen, and not be able to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance. Patients must also meet all in- and exclusion criteria. TMC125 (200mg twice daily) will be provided once the patient has been confirmed eligible for entry. Once treatment with TMC125 in combination with other ARVs has been initiated, patients must be instructed to follow the recommended visit schedule based on routine clinical care. Safety and tolerability of the entire antiretroviral therapy (ART) regimen, including TMC125, should be monitored by the investigator as per standard clinical practice. However, it is recommended that visits be planned 4 and 12 weeks following initiation of TMC125 in combination with other ARVs and every 12 weeks thereafter while on therapy during this trial. Adverse events (AEs) leading to treatment interruption or discontinuation and all serious adverse events (SAEs), with the exception of Acquired Immunodeficiency Syndrome (AIDS) defining illnesses (CDC class C) unless fatal or considered to be related to TMC125, will be collected. Other adverse events will be collected only if required as per local regulations. The background ARVs may be changed at any time during the trial, at the discretion of the investigator due to the development of resistance, intolerance, toxicity, etc. while continuing treatment with TMC125 if in the investigator's assessment the patient still benefits from treatment with TMC125. If changes in the background regimen are made, it is recommended that a follow-up visit be planned 4 weeks after the change in therapy. Treatment with investigational medication will be continued until virologic failure, treatment-limiting toxicity, subject lost to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country. Patients will be instructed to orally take two 100 mg tablets of TMC125 following a meal every 12 hours. TMC125 (200 mg twice daily) must be used in combination with other antiretroviral drugs. Treatment with investigational medication will continue until virologic failure, treatment-limiting toxicity, patient lost to follow-up, withdrawal, pregnancy, discontinuation of TMC125 development or when TMC125 becomes commercially available in the patient's country.

Study Type

Expanded Access

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
      • Bruges, Belgium
      • Brussels, Belgium
      • Charleroi, Belgium
      • Ghent, Belgium
      • Leuven, Belgium
      • Liège, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • New Brunswick
      • Moncton, New Brunswick, 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
      • Ste-Foy, Quebec, Canada
  • Denmark
      • Aarhus, Denmark
      • Copenhagen, Denmark
      • Hvidovre, Denmark
      • Odense, Denmark
  • Germany
      • Aachen, Germany
      • Berlin, Germany
      • Bochum, Germany
      • Bonn, Germany
      • Cologne, Germany
      • Düsseldorf, Germany
      • Erlangen, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Freiburg im Breisgau, Germany
      • Hamburg, Germany
      • Hanover, Germany
      • Koblenz, Germany
      • Mainz, Germany
      • Mannheim, Germany
      • Munich, Germany
      • München, Germany
      • Münster, Germany
      • Osnabrück, Germany
      • Stuttgart, Germany
      • Würzburg, Germany
  • Greece
      • Athens, Greece
      • Pátrai, Greece
      • Thessalonikis, Greece
  • Luxembourg
      • Luxembourg, Luxembourg
  • Mexico
      • Bosques Del Nogalar San Nicola, Mexico
      • Chihuahua City, Mexico
      • Col Tacuba, Mexico
      • Guadalajara, Mexico
      • León, Mexico
      • Mexico City, Mexico
      • Monterrey Nuevo León, Mexico
      • Oaxaca City, Mexico
      • Puebla City, Mexico
      • Tabasco, Mexico
      • Tijuana, Mexico
      • Veracruz, Mexico
  • Netherlands
      • Alkmaar, Netherlands
      • Amsterdam, Netherlands
      • Amsterdam-Zuidoost, Netherlands
      • Arnhem, Netherlands
      • Eindhoven, Netherlands
      • Groningen, Netherlands
      • Leiden, Netherlands
      • Maastricht, Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
      • The Hague, Netherlands
      • Tilburg, Netherlands
      • Utrecht, Netherlands
  • Puerto Rico
      • San Juan, Puerto Rico
  • Russia
      • Kazan', Russia
      • Moscow, Russia
      • Oryol, Russia
      • Saint Petersburg, Russia
      • Smolensk, Russia
      • Volgograd, Russia
  • South Korea
      • Kyungki, South Korea
      • Pusan, South Korea
      • Seoul, South Korea
  • Spain
      • A Coruña, Spain
      • Alicante, Spain
      • Barakaldo Vizcaya, Spain
      • Barcelona, Spain
      • Bilbao, Spain
      • Cadiz, Spain
      • Cuenca, Spain
      • Córdoba, Spain
      • Donostia Guipuzcoa, Spain
      • Elche, Spain
      • Granada, Spain
      • Granollers, Spain
      • Logroño, Spain
      • Madrid, Spain
      • Murcia, Spain
      • Málaga, Spain
      • Oviedo, Spain
      • Palma de Mallorca, Spain
      • Pamplona, Spain
      • Sabadell, Spain
      • San Cristóbal de La Laguna, Spain
      • Santa Cruz de Tenerife, Spain
      • Santiago de Compostela (La Cor, Spain
      • Seville, Spain
      • Terrassa, Spain
      • Valencia, Spain
      • Vigo, Spain
      • Vitoria-Gasteiz, Spain
      • Zaragoza, Spain
  • Sweden
      • Gothenburg, Sweden
      • Malmö, Sweden
      • Stockholm, Sweden
  • Taiwan
      • Kaohsiung City, Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
  • United States
    • Alabama
      • Anniston, Alabama, United States
      • Birmingham, Alabama, United States
    • Arizona
      • Flagstaff, Arizona, United States
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Arcata, California, United States
      • Bakersfield, California, United States
      • Baldwin Park, California, United States
      • Bellflower, California, United States
      • Beverly Hills, California, United States
      • Fontana, California, United States
      • Fountain Valley, California, United States
      • Fremont, California, United States
      • Garden Grove, 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
      • Newport Beach, California, United States
      • Oakland, California, United States
      • Palm Springs, California, United States
      • Palo Alto, California, United States
      • Panorama City, California, United States
      • Pasadena, California, United States
      • Pico Rivera, California, United States
      • Richmond, California, United States
      • Sacramento, California, United States
      • San Bernardino, 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
      • Tarzana, California, United States
      • Ukiah, California, United States
      • Ventura, California, United States
      • Woodland Hills, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Wheat Ridge, 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
    • District of Columbia
      • Washington D.C., District of Columbia, United States
    • Florida
      • Daytona Beach, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • LaBelle, Florida, United States
      • Leesburg, Florida, United States
      • Miami, Florida, United States
      • Miami Beach, Florida, United States
      • North Miami Beach, Florida, United States
      • North Palm Beach, Florida, United States
      • Oakland Park, Florida, United States
      • Orlando, Florida, United States
      • Pensacola, 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
      • Tarpon Springs, Florida, United States
      • Vero Beach, Florida, United States
      • West Palm Beach, Florida, United States
      • Weston, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
      • Jesup, Georgia, United States
      • Macon, Georgia, United States
      • Riverdale, Georgia, United States
      • Savannah, Georgia, United States
      • Tucker, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Aurora, Illinois, United States
      • Chicago, Illinois, United States
      • Joliet, Illinois, United States
      • Maywood, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
      • Iowa City, Iowa, United States
    • Kentucky
      • Henderson, Kentucky, United States
      • Paducah, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maine
      • Ellsworth, Maine, United States
      • Portland, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Greenbelt, Maryland, United States
      • Silver Spring, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Springfield, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Berkley, Michigan, United States
      • Detroit, Michigan, United States
      • Grand Rapids, Michigan, United States
      • Grosse Pointe Woods, Michigan, United States
      • Lansing, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Rochester, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
      • St Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Rochester, New Hampshire, United States
    • New Jersey
      • Englewood, New Jersey, United States
      • Hackensack, New Jersey, United States
      • Long Branch, 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
      • Union, New Jersey, United States
      • Voorhees Township, New Jersey, United States
      • Westfield, New Jersey, United States
    • New Mexico
      • Santa Fe, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Briarcliff Manor, New York, United States
      • Brooklyn, New York, United States
      • Buffalo, New York, United States
      • East Meadow, New York, United States
      • Elmira, New York, United States
      • Flushing, New York, United States
      • Kingston, 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
      • Staten Island, New York, United States
      • The Bronx, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Gastonia, North Carolina, United States
      • Huntersville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Johnstown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
    • Tennessee
      • Johnson City, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Bellaire, Texas, United States
      • Dallas, Texas, United States
      • El Paso, Texas, United States
      • Fort Worth, Texas, United States
      • Harlingen, Texas, United States
      • Houston, 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
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Olympia, Washington, United States
      • Seattle, Washington, United States
      • Spokane, Washington, United States
      • Yakima, Washington, United States
    • West Virginia
      • Charleston, West Virginia, United States
    • Wisconsin
      • La Crosse, Wisconsin, United States
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMC125
TMC125 200 mg b.i.d. till commercially available.
Drug: TMC125
200 mg b.i.d. till commercially available.

What is the study measuring?

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.
pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
pregnancy, discontinuation of TMC125 development or when TMC125 has become commercially available in the patient's country.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tibotec Pharmaceuticals, Ireland

Investigators

  • Study Director: Tibotec Pharmaceuticals Clinical Trial, Tibotec Pharmaceutical Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 18, 2006

First Posted (Estimated)

July 20, 2006

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

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