TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110877
Recruitment Status : Completed
First Posted : May 16, 2005
Last Update Posted : July 3, 2015
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Brief Summary:
Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: LPV/rtv Drug: TMC114/rtv Phase 3

Detailed Description:
Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIV(viral load) in the blood. People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both. The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir. Kaletra (LPV/RTV) is either a tablet or capsule taken twice a day. The oral capsule contains 133.3 mg LPV, 33.3 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients
Study Start Date : April 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 002
LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV
Drug: LPV/rtv
One 400mg LPV tablet twice daily with 100mg RTV
Experimental: 001
TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV
Drug: TMC114/rtv
Two 300mg TMC114 tablets twice daily with 100mg RTV

Primary Outcome Measures :
  1. Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population) [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 96 weeks ]
  2. Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population) [ Time Frame: 96 Weeks ]

Information from the National Library of Medicine

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has documented HIV-1 infection
  • Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks
  • Plasma HIV-1 RNA >1000 copies/mL
  • General medical condition does not interfere with the assessments and the completion of the trial

Exclusion Criteria:

  • Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
  • tenofovir, emtricitabine, atazanavir, fosamprenavir
  • Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114
  • Life expectancy of less than 6 months
  • Pregnant or breast-feeding
  • Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period
  • Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels
  • Participation in other investigational trials without prior approval of the sponsor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110877

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Beverly Hills, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Francisco, California, United States
West Hollywood, California, United States
United States, Colorado
Denver, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Ft Lauderdale, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Safety Harbor, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Macon, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Berkley, Michigan, United States
United States, New Jersey
Camden, New Jersey, United States
East Orange, New Jersey, United States
Newark, New Jersey, United States
United States, New York
Bronx, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Huntersville, North Carolina, United States
Winston Salem, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
United States, Virginia
Hampton, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Buenos Aires, Argentina
Cordoba, Argentina
Rosario, Argentina
Darlinghurst, Australia
Melbourne, Australia
Perth, Australia
Surry Hills, Australia
Wien N/A, Austria
Wien, Austria
Antwerpen, Belgium
Brussels, Belgium
Curitiba, Brazil
Distrito Barao Geraldo-Campina, Brazil
Nova Iguacu, Brazil
Pinheiros, Brazil
Rio De Janeiro, Brazil
Sao Paulo, Brazil
Canada, Alberta
Calgary, Alberta, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Providencia, Chile
Santiago, Chile
Aalborg, Denmark
Nice, France
Paris Cedex 10, France
Paris Cedex 12, France
Paris, France
Rennes, France
Villejuif Cedex, France
Aachen, Germany
Berlin, Germany
Düsseldorf, Germany
Hamburg, Germany
Köln, Germany
Mannheim, Germany
Osnabrück, Germany
Stuttgart, Germany
Melissia-Athens, Greece
Guatemala, Guatemala
Budapest, Hungary
Kuala Lumpur, Malaysia
Sungai Buloh, Malaysia
Guadalajara, Mexico
Amsterdam, Netherlands
Groningen, Netherlands
Rotterdam, Netherlands
Panama, Panama
Lisboa, Portugal
Porto, Portugal
Puerto Rico
San Juan, Puerto Rico
Russian Federation
Kazan, Russian Federation
Moscow N/A, Russian Federation
Nizhny Novgorod, Russian Federation
Saint-Petersburg, Russian Federation
St Petersburg, Russian Federation
Volgograd, Russian Federation
South Africa
Cape Town, South Africa
Durban, South Africa
Houghton, Johannesburg, South Africa
Johannesburg, South Africa
Pretoria, South Africa
Barcelona, Spain
Madrid, Spain
Zurich N/A, Switzerland
Bangkok, Thailand
Khon Kaen, Thailand
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tibotec Pharmaceuticals, Ireland Identifier: NCT00110877     History of Changes
Obsolete Identifiers: NCT00980902
Other Study ID Numbers: CR002794
TMC114-C214 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
First Posted: May 16, 2005    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015

Keywords provided by Tibotec Pharmaceuticals, Ireland:
Human Immunodeficiency Virus
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents