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

NCT ID: NCT00354627

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 5178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-03-31

Brief 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 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.

Conditions

HIV-1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMC125

TMC125 200 mg b.i.d. till commercially available.

Group Type: EXPERIMENTAL

TMC125

Intervention Type: DRUG

200 mg b.i.d. till commercially available.

Interventions

TMC125

200 mg b.i.d. till commercially available.

Intervention Type: DRUG

Eligibility Criteria

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])
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tibotec Pharmaceuticals, Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibotec Pharmaceuticals Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceutical Limited

Locations

Anniston, Alabama, United States

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Anaheim, California, United States

Arcata, California, United States

Bakersfield, California, United States

Beverly Hills, California, United States

Fontana, California, United States

Fountain Valley, California, United States

Garden Grove, 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

Panorama City, California, United States

Sacramento, 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

Woodland Hills, California, United States

Denver, Colorado, United States

Wheat Ridge, Colorado, United States

Glastonbury, Connecticut, United States

New Haven, Connecticut, United States

Norwalk, Connecticut, United States

Norwich, Connecticut, United States

Washington D.C., District of Columbia, United States

Daytona Beach, Florida, United States

Fort Lauderdale, Florida, United States

Fort Laudersale, Florida, United States

Hollywood, Florida, United States

LaBelle, Florida, United States

Leesburg, Florida, United States

Miami, Florida, United States

North Miami Beach, Florida, United States

North Palm Beach, 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

Winter Park, Florida, United States

Atlanta, Georgia, United States

Jesup, Georgia, United States

Macon, Georgia, United States

Riverdale, Georgia, United States

Savannah, Georgia, United States

Tucker, Georgia, United States

Honolulu, Hawaii, United States

Aurora, Illinois, United States

Chicago, Illinois, United States

Maywood, Illinois, United States

Indianapolis, Indiana, United States

Des Moines, Iowa, United States

Iowa City, Iowa, United States

Henderson, Kentucky, United States

Paducah, Kentucky, United States

New Orleans, Louisiana, United States

Ellsworth, Maine, United States

Portland, Maine, United States

Baltimore, Maryland, United States

Silver Spring, Maryland, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Grand Rapids, Michigan, United States

Grosse Pointe Woods, Michigan, United States

Minneapolis, Minnesota, United States

Rochester, Minnesota, United States

Saint Louis Park, Minnesota, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Lincoln, Nebraska, United States

Las Vegas, Nevada, United States

Rochester, New Hampshire, United States

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

Voorhees Township, New Jersey, United States

Westfield, New Jersey, United States

Santa Fe, New Mexico, United States

Briarcliff, 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

New York, New York, United States

Rochester, New York, United States

Staten Island, New York, United States

The Bronx, New York, United States

Chapel Hill, North Carolina, United States

Gastonia, North Carolina, United States

Huntersville, North Carolina, United States

Winston-Salem, North Carolina, United States

Akron, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Portland, Oregon, United States

Allentown, Pennsylvania, United States

Johnstown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Providence, Rhode Island, United States

Columbia, South Carolina, United States

Johnson City, Tennessee, United States

Nashville, Tennessee, United States

Austin, 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

Annandale, Virginia, United States

Charlottesville, Virginia, United States

Fairfax, Virginia, United States

Hampton, Virginia, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Olympia, Washington, United States

Seattle, Washington, United States

Spokane, Washington, United States

Yakima, Washington, United States

Charleston, West Virginia, United States

La Crosse, Wisconsin, United States

Madison, Wisconsin, United States

Milwaukee, Wisconsin, United States

Antwerp, , Belgium

Bruges, , Belgium

Brussels, , Belgium

Charleroi, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Moncton, New Brunswick, 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

Ste-Foy, Quebec, Canada

Aarhus, , Denmark

Copenhagen, , Denmark

Hvidovre, , Denmark

Odense, , Denmark

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

Mainz, , Germany

Mannheim, , Germany

Munich, , Germany

München, , Germany

Münster, , Germany

Osnabrück, , Germany

Stuttgart, , Germany

Würzburg, , Germany

Athens, , Greece

Pátrai, , Greece

Thessalonikis, , Greece

Luxembourg, , Luxembourg

Bosques Del Nogalar San Nicola, , Mexico

Chihuahua City, , Mexico

Col Tacuba, , Mexico

Guadalajara, , Mexico

Mexico City, , Mexico

Monterrey Nuevo León, , Mexico

Puebla City, , Mexico

Tijuana, , Mexico

Alkmaar, , Netherlands

Amsterdam, , Netherlands

Amsterdam-Zuidoost, , Netherlands

Arnhem, , Netherlands

Groningen, , Netherlands

Leiden, , Netherlands

Maastricht, , Netherlands

Nijmegen, , Netherlands

Rotterdam, , Netherlands

The Hague, , Netherlands

Tilburg, , Netherlands

Utrecht, , Netherlands

San Juan, , Puerto Rico

Moscow, , Russia

Saint Petersburg, , Russia

Volgograd, , Russia

Kyungki, , South Korea

Pusan, , South Korea

Seoul, , South Korea

Alicante, , Spain

Barcelona, , Spain

Bilbao, , Spain

Cadiz, , Spain

Cuenca, , Spain

Elche, , Spain

Granada, , Spain

Granollers, , Spain

Logroño, , Spain

Madrid, , Spain

Málaga, , Spain

Murcia, , Spain

Oviedo, , 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

Gothenburg, , Sweden

Malmo, , Sweden

Stockholm, , Sweden

Kaohsiung City, , Taiwan

Taipei, , Taiwan

Ankara, , Turkey (Türkiye)

Countries

United States; Belgium; Canada; Denmark; Germany; Greece; Luxembourg; Mexico; Netherlands; Puerto Rico; Russia; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=982&filename=CR002743_CSR.pdf

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

Other Identifiers

TMC125-C214

Identifier Type: OTHER

Identifier Source: secondary_id

CR002743

Identifier Type: -

Identifier Source: org_study_id

NCT00613236

Identifier Type: -

Identifier Source: nct_alias