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Clinical Trials

MainTitle

An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

This study has been completed
Sponsor
Tibotec Pharmaceuticals, Ireland


Information provided by (Responsible Party)
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier
NCT00081588

First received: April 15, 2004
Last updated: June 19, 2014
Last Verified: June 2014
History of Changes
Purpose

Purpose

The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

Condition Intervention Phase
HIV Infection

Drug : TMC114
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures

  • The primary parameter is the confirmed virologic response at Week 24 (a drop in viral load (copies/mL) of at least 1 log10 versus baseline. [ Time Frame: 24 weeks ]
Secondary Outcome Measures:
  • Proportion of patients with a virologic response; with plasma HIV-1 RNA levels < 50 copies/mL; with plasma HIV-1 RNA levels < 400 copies/mL; Time to loss of virologic response over 144 week treatment period; Change in plasma viral load at all time points [ Time Frame: 144 weeks ]

Enrollment: 555
Study Start Date: November 2003
Study Completion Date: December 2008
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 001
TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
Drug: TMC114

600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available

Detailed Description:

The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria. It is estimated that approximately 150 patients may meet these criteria. Major inclusion and exclusion criteria are listed below. For new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (NRTI), one non-nucleoside reverse transcriptase inhibitor (NNRTI) and a protease inhibitor (PI). At least one primary PI mutation must be present at screening. Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study. All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study. The recruitment of new patients for the TMC114-C215 trial has been fully enrolled. The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study. Two 300mg/100mg Darunavir/Ritonavir tablets twice daily for 144 weeks.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Previous participation in the TMC114-C202 or TMC114-C213 trials
  • Significant virologic failure during participation in the above trials
  • Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
  • Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
  • Patient has given informed consent


Exclusion Criteria:
  • Use of disallowed concomitant therapy
  • Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
  • Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
  • Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol
  • Patient withdrawing consent from TMC114-C202 or TMC114-C213

contacts and locations

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: NCT00081588

Locations

United States, Alabama
Birmingham, Alabama, United States
United States, California
Beverly Hills, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Oakland, California, United States
San Francisco, California, 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
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
Springfield, Massachusetts, United States
United States, New Jersey
Camden, New Jersey, United States
United States, New York
Albany, New York, United States
New York, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Galveston, Texas, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Argentina
Buenos Aires, Argentina
Australia
Darlinghurst, Australia
Melbourne, Australia
Perth, Australia
Austria
Vienna, Austria
Wien, Austria
Belgium
Brussels, Belgium
Brussel, Belgium
Gent, Belgium
Brazil
Campinas, Brazil
Curitiba, Brazil
Rio De Janeiro, Brazil
Sao Paulo, Brazil
Canada
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
France
Le Kremlin Bicetre, France
Montpellier, France
Nantes, France
Paris Cedex 10, France
Paris Cedex 12, France
Paris, France
Toulon, France
Villejuif Cedex, France
Germany
Berlin, Germany
Bonn, Germany
Düsseldorf, Germany
Essen, Germany
Freiburg, Germany
Hamburg, Germany
Kÿln, Germany
Mannheim, Germany
Munich, Germany
Hungary
Budapest, Hungary
Portugal
Lisboa, Portugal
Porto, Portugal
Spain
Barakaldo Vizcaya S/N, Spain
Barcelona N/A, Spain
Madrid, Spain
United Kingdom
Edinburgh, United Kingdom
London, United Kingdom
Manchester, United Kingdom

Sponsors and Collaborators

Tibotec Pharmaceuticals, Ireland

Investigators

Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
More Information

More Information


Responsible Party: Tibotec Pharmaceuticals, Ireland  
ClinicalTrials.gov Identifier: NCT00081588   History of Changes  
Other Study ID Numbers: CR006724  
  TMC114-C215  
Study First Received: April 15, 2004  
Last Updated: June 19, 2014  

Keywords provided by Tibotec Pharmaceuticals, Ireland:

TMC114-C215
Ritonavir
HIV infections
TMC114-C202
TMC114-C213

Additional relevant MeSH terms:
HIV Infections
Darunavir

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.