HIV-1NCT00354627
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
A study testing TMC125 in people with HIV-1, run by Tibotec Pharmaceuticals, Ireland at 304 sites in 16 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1
- What is being tested?
- TMC125
- How many people
- Not given
- Where
- 304 sitesin 16 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
304 sites in 16 countries.
304 sites in 16 countries
United States182 sites
Study site
Akron, Ohio
Study site
Albany, New York
Study site
Allentown, Pennsylvania
Study site
Anaheim, California
Study site
Ann Arbor, Michigan
Study site
Annandale, Virginia
Study site
Anniston, Alabama
Study site
Arcata, California
Study site
Atlanta, Georgia
Study site
Aurora, Illinois
Study site
Austin, Texas
Study site
Bakersfield, California
Study site
Baldwin Park, California
Study site
Baltimore, Maryland
Study site
Bellaire, Texas
Study site
Bellflower, California
Study site
Berkley, Michigan
Study site
Beverly Hills, California
Study site
Birmingham, Alabama
Study site
Boise, Idaho
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Boston, Massachusetts
Study site
Briarcliff Manor, New York
Study site
Brooklyn, New York
Study site
Buffalo, New York
Study site
Chapel Hill, North Carolina
Study site
Charleston, South Carolina
Study site
Charleston, West Virginia
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Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Columbia, South Carolina
Study site
Columbus, Ohio
Study site
Dallas, Texas
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Dayton, Ohio
Study site
Daytona Beach, Florida
Study site
Decatur, Georgia
Study site
Denver, Colorado
Study site
Des Moines, Iowa
Study site
Detroit, Michigan
Study site
East Meadow, New York
Study site
El Paso, Texas
Study site
Ellsworth, Maine
Study site
Elmira, New York
Study site
Englewood, New Jersey
Study site
Fairfax, Virginia
Study site
Flagstaff, Arizona
Study site
Flushing, New York
Study site
Fontana, California
Study site
Fort Lauderdale, Florida
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
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Fremont, California
Study site
Garden Grove, California
Study site
Gastonia, North Carolina
Study site
Glastonbury, Connecticut
Study site
Glendale, California
Study site
Grand Rapids, Michigan
Study site
Greenbelt, Maryland
Study site
Grosse Pointe Woods, Michigan
Study site
Hackensack, New Jersey
Study site
Hampton, Virginia
Study site
Harbor City, California
Study site
Harlingen, Texas
Study site
Hartford, Connecticut
Study site
Hayward, California
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Henderson, Kentucky
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Hollywood, Florida
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Honolulu, Hawaii
Study site
Houston, Texas
Study site
Huntersville, North Carolina
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Indianapolis, Indiana
Study site
Iowa City, Iowa
Study site
Jacksonville, Florida
Study site
Jesup, Georgia
Study site
Johnson City, Tennessee
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Johnstown, Pennsylvania
Study site
Joliet, Illinois
Study site
Kansas City, Missouri
Study site
Kingston, New York
Study site
La Crosse, Wisconsin
Study site
LaBelle, Florida
Study site
Lansing, Michigan
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Las Vegas, Nevada
Study site
Leesburg, Florida
Study site
Lincoln, Nebraska
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Little Rock, Arkansas
Study site
Loma Linda, California
Study site
Long Beach, California
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Long Branch, New Jersey
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Longview, Texas
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Los Angeles, California
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Macon, Georgia
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Madison, Wisconsin
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Manhasset, New York
Study site
Maywood, Illinois
Study site
Miami, Florida
Study site
Miami Beach, Florida
Study site
Milwaukee, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Mount Vernon, New York
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Nashville, Tennessee
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Neptune City, New Jersey
Study site
New Haven, Connecticut
Study site
New Orleans, Louisiana
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New York, New York
Study site
Newark, New Jersey
Study site
Newport Beach, California
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Norfolk, Virginia
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North Miami Beach, Florida
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North Palm Beach, Florida
Study site
Norwalk, Connecticut
Study site
Norwich, Connecticut
Study site
Oakland, California
Study site
Oakland Park, Florida
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Olympia, Washington
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Orlando, Florida
Study site
Paducah, Kentucky
Study site
Palm Springs, California
Study site
Palo Alto, California
Study site
Panorama City, California
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Pasadena, California
Study site
Pensacola, Florida
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Perth Amboy, New Jersey
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Philadelphia, Pennsylvania
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Phoenix, Arizona
Study site
Pico Rivera, California
Study site
Pittsburgh, Pennsylvania
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Plantation, Florida
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Port Saint Lucie, Florida
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Portland, Maine
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Portland, Oregon
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Providence, Rhode Island
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Richmond, California
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Richmond, Virginia
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Riverdale, Georgia
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Rochester, Minnesota
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Rochester, New Hampshire
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Rochester, New York
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Sacramento, California
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Safety Harbor, Florida
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Saint Louis Park, Minnesota
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San Antonio, Texas
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San Bernardino, California
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San Diego, California
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San Francisco, California
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San Mateo, California
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San Rafael, California
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Santa Ana, California
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Santa Clara, California
Study site
Santa Clarita, California
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Santa Fe, New Mexico
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Santa Rosa, California
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Sarasota, Florida
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Savannah, Georgia
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Seattle, Washington
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Silver Spring, Maryland
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Somers Point, New Jersey
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Spokane, Washington
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Springfield, Massachusetts
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St Louis, Missouri
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Stanford, California
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Staten Island, New York
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Tampa, Florida
Study site
Tarpon Springs, Florida
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Tarzana, California
Study site
The Bronx, New York
Study site
Tucker, Georgia
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Tucson, Arizona
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Ukiah, California
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Union, New Jersey
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Ventura, California
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Vero Beach, Florida
Study site
Voorhees Township, New Jersey
Study site
Washington D.C., District of Columbia
Study site
West Palm Beach, Florida
Study site
Westfield, New Jersey
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Weston, Florida
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Wheat Ridge, Colorado
Study site
Winston-Salem, North Carolina
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Winter Park, Florida
Study site
Woodland Hills, California
Study site
Yakima, Washington
Spain29 sites
Study site
A Coruña
Study site
Alicante
Study site
Barakaldo Vizcaya
Study site
Barcelona
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Bilbao
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Cadiz
Study site
Córdoba
Study site
Cuenca
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Donostia Guipuzcoa
Study site
Elche
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Granada
Study site
Granollers
Study site
Logroño
Study site
Madrid
Study site
Málaga
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Murcia
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Oviedo
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Palma de Mallorca
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Pamplona
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Sabadell
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San Cristóbal de La Laguna
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Santa Cruz de Tenerife
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Santiago de Compostela (La Cor
Study site
Seville
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Terrassa
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Valencia
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Vigo
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Vitoria-Gasteiz
Study site
Zaragoza
Germany21 sites
Study site
Aachen
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Berlin
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Bochum
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Bonn
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Cologne
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Düsseldorf
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Erlangen
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Essen
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Frankfurt
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Freiburg im Breisgau
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Hamburg
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Hanover
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Koblenz
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Mainz
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Mannheim
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München
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Munich
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Münster
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Osnabrück
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Stuttgart
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Würzburg
Canada14 sites
Study site
Calgary, Alberta
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Edmonton, Alberta
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Hamilton, Ontario
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Kingston, Ontario
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London, Ontario
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Moncton, New Brunswick
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Montreal, Quebec
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Ottawa, Ontario
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Ste-Foy, Quebec
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Toronto, Ontario
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Vancouver, British Columbia
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Whitby, Ontario
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Windsor, Ontario
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Winnipeg, Manitoba
Netherlands13 sites
Study site
Alkmaar
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Amsterdam
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Amsterdam-Zuidoost
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Arnhem
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Eindhoven
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Groningen
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Leiden
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Maastricht
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Nijmegen
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Rotterdam
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The Hague
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Tilburg
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Utrecht
Mexico12 sites
Study site
Bosques Del Nogalar San Nicola
Study site
Chihuahua City
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Col Tacuba
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Guadalajara
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León
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Mexico City
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Monterrey Nuevo León
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Oaxaca City
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Puebla City
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Tabasco
Study site
Tijuana
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Veracruz
Belgium7 sites
Study site
Antwerp
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Bruges
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Brussels
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Charleroi
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Ghent
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Leuven
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Liège
Russia6 sites
Study site
Kazan'
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Moscow
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Oryol
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Saint Petersburg
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Smolensk
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Volgograd
Denmark4 sites
Study site
Aarhus
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Copenhagen
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Hvidovre
Study site
Odense
Taiwan4 sites
Study site
Kaohsiung City
Study site
Taichung
Study site
Tainan
Study site
Taipei
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV-1
- Being tested
- TMC125
- Keywords
- HIV-1, Early Access Program (EAP), TMC125, treatment-experienced, failing multiple antiretroviral (ARV) regimens, limited to no treatment options
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC125Drug
200 mg b.i.d. till commercially available.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354627
- Sponsor's protocol ID
- CR002743
- Other IDs
- TMC125-C214
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2006
- Last updated
- 4 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Access of TMC125 in Combination With Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects With Limited Treatment Options
- ClinicalTrials.gov ID
- NCT00354627
- Acronym / sponsor ID
- CR002743
- Conditions
- HIV-1
- Keywords
- HIV-1, Early Access Program (EAP), TMC125, treatment-experienced, failing multiple antiretroviral (ARV) regimens, limited to no treatment options
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMC125200 mg b.i.d. till commercially available. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Early Access of TMC125 in Combination with Other Antiretrovirals in Treatment Experienced HIV-1 Infected Subjects with Limited Treatment OptionsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibotec Pharmaceuticals Clinical Trial study director
Tibotec Pharmaceutical Limited
304 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMC125 in people with HIV-1, run by Tibotec Pharmaceuticals, Ireland at 304 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 304 sites in United States, Spain, Germany, Canada, Netherlands and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.