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

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00110877
First received: May 13, 2005
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
HIV Infection
Drug: LPV/rtv
Drug: TMC114/rtv
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • Change in viral load at 48 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate safety, tolerability and durability of efficacy over 96 weeks. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 604
Study Start Date: April 2005
Study Completion Date: October 2011
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110877

  Hide Study Locations
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
Argentina
Buenos Aires, Argentina
Cordoba, Argentina
Rosario, Argentina
Australia
Darlinghurst, Australia
Melbourne, Australia
Perth, Australia
Surry Hills, Australia
Austria
Wien, Austria
Wien N/A, Austria
Belgium
Antwerpen, Belgium
Brussels, Belgium
Brazil
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
Chile
Providencia, Chile
Santiago, Chile
Denmark
Aalborg, Denmark
France
Nice, France
Paris, France
Paris Cedex 10, France
Paris Cedex 12, France
Rennes, France
Villejuif Cedex, France
Germany
Aachen, Germany
Berlin, Germany
Düsseldorf, Germany
Hamburg, Germany
Köln, Germany
Mannheim, Germany
Osnabrück, Germany
Stuttgart, Germany
Greece
Melissia-Athens, Greece
Guatemala
Guatemala, Guatemala
Hungary
Budapest, Hungary
Malaysia
Kuala Lumpur, Malaysia
Sungai Buloh, Malaysia
Mexico
Guadalajara, Mexico
Netherlands
Amsterdam, Netherlands
Groningen, Netherlands
Rotterdam, Netherlands
Panama
Panama, Panama
Portugal
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
Spain
Barcelona, Spain
Madrid, Spain
Switzerland
Zurich N/A, Switzerland
Thailand
Bangkok, Thailand
Khon Kaen, Thailand
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Compound Development Team Leader TMC114, Tibotec Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT00110877     History of Changes
Obsolete Identifiers: NCT00980902
Other Study ID Numbers: CR002794, TMC114-C214
Study First Received: May 13, 2005
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority
Great Britain: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Tibotec Pharmaceuticals, Ireland:
Human Immunodeficiency Virus
Treatment Experienced
TMC114-C214

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014