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

June 19, 2014 updated by: Tibotec Pharmaceuticals, Ireland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

555

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
  • Australia
      • Darlinghurst, Australia
      • Melbourne, Australia
      • Perth, Australia
  • Austria
      • Vienna, Austria
      • Wien, Austria
  • Belgium
      • Brussel, Belgium
      • Brussels, Belgium
      • Gent, Belgium
  • Brazil
      • Campinas, Brazil
      • Curitiba, Brazil
      • Rio De Janeiro, Brazil
      • Sao Paulo, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Le Kremlin Bicetre, France
      • Montpellier, France
      • Nantes, France
      • Paris, France
      • Paris Cedex 10, France
      • Paris Cedex 12, 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
  • United States
    • Alabama
      • Birmingham, Alabama, 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
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Ft Lauderdale, Florida, United States
      • Miami, Florida, United States
      • Vero Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Macon, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Springfield, Massachusetts, United States
    • New Jersey
      • Camden, New Jersey, United States
    • New York
      • Albany, New York, United States
      • New York, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States
      • Galveston, Texas, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
144 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tibotec Pharmaceuticals, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 15, 2004

First Submitted That Met QC Criteria

April 16, 2004

First Posted (Estimate)

April 19, 2004

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR006724
  • TMC114-C215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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