An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).

May 6, 2014 updated by: Tibotec Pharmaceuticals, Ireland

An Open-label Trial With TMC125 as Part of an ART Including TMC114/Rtv and an Investigator-selected OBR in HIV-1 Infected Subjects Who Participated in a DUET Phase III Trial (TMC125-C206 or TMC125-C216).

The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III open-label, roll-over trial to evaluate the long term tolerability, safety, antiviral and immunological effect of TMC125 as part of an individually optimized antiretroviral therapy including TMC114/rtv in HIV-1 infected patients who participated in one of the DUET (TMC125-C206 or TMC125-C216) trials. Also the change in HIV-1 resistance over time will be evaluated. This trial offers patients meeting the definition of virologic failure at Week 24 or beyond the option to roll-over to an open-label trial where they will receive TMC125 and TMC114/rtv. Three hundred patients are estimated to enroll into this trial. The withdrawal visit of the DUET trial will be the first visit of this trial. From this visit onward, all patients will receive 200 mg twice daily TMC125 and 600/100 mg twice daily TMC114/rtv until both TMC114 and TMC125 are commercially available or the therapy is no longer of clinical benefit to the patient. Patients will receive an antiretroviral therapy consisting of TMC125 as the only non-nucleoside reverse transcriptase inhibitor (NNRTI), TMC114/rtv as the only protease inhibitor (PI) and an optimized background, which will be selected by the investigator according to the local standard of care, the patient's experience with previous therapies and most recent resistance testing. The most recent HIV-1 genotype-analysis system report results from the DUET trial will be made available. TMC125 will be dosed at 200 mg twice daily, administered orally as 2 tablets twice daily with food.TMC114/rtv will be dosed at 600/100 mg twice daily, administered orally as 2 tablets TMC114 and 1 capsule ritonavir twice daily with food.The optimized background will comprise of at least 1 approved ARV drug: 1 or more NRTI(s), with or without ENF. Administration will continue until both TMC114 and TMC125 are commercially available or therapy is no longer of clinical benefit to the patient.

Study Type

Interventional

Enrollment (Actual)

503

Phase

  • Phase 3

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
      • Cordoba, Argentina
      • Florencio Varela, Argentina
      • Neuquen, Argentina
  • Australia
      • Darlinghurst, Australia
  • Belgium
      • Antwerpen, Belgium
      • Liege, Belgium
  • Brazil
      • Curitiba, Brazil
      • Rio De Janeiro, Brazil
      • Salvador, Brazil
      • Sao Paulo, Brazil
  • Canada
      • Toronto, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Chile
      • Providencia, Chile
      • Santiago, Chile
  • France
      • Bordeaux Cedex, France
      • Bordeaux N/A, France
      • Le Kremlin Bicetre, France
      • Lyon, France
      • Marseille Cedex 09, France
      • Paris, France
      • Paris Cedex 10, France
      • Paris Cedex 12, France
      • Paris Cedex 15, France
      • Paris, 75, France
      • Rennes, France
      • Toulouse, France
      • Tourcoing, France
      • Villejuif N/A, France
  • Germany
      • Berlin, Germany
      • Essen, Germany
      • Hamburg, Germany
      • Mannheim, Germany
      • München, Germany
  • Mexico
      • Ciudad De Mexico, Mexico
      • Mex Ctity, Mexico
  • Panama
      • Panama, Panama
  • Puerto Rico
      • San Juan, Puerto Rico
  • Spain
      • Barcelona, Spain
      • Barcelona N/A, Spain
      • Madrid, Spain
      • Valencia, Spain
  • Thailand
      • Bangkok, Thailand
      • Khon Kaen, Thailand
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Beverly Hills, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Palm Springs, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
    • Colorado
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Fort Laudersale, Florida, United States
      • Ft Lauderdale, Florida, United States
      • Miami, Florida, United States
      • N Miami Beach, Florida, United States
      • Safety Harbor, Florida, United States
      • Tampa, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • New Jersey
      • Camden, New Jersey, United States
      • Newark, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Longview, Texas, United States
    • Virginia
      • Annandale, Virginia, United States
    • Washington
      • Seattle, Washington, 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:

  • Patient was previously randomized in a DUET (TMC125-C206 or TMC125-C216) trial and completed at least 24 weeks of treatment
  • Patient was virologically failing in a DUET trial.

Exclusion Criteria:

  • Use of disallowed concomitant therapy
  • Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table
  • Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials because of any of the mandatory withdrawal criteria of that trial.

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
TMC125 200 mg twice daily until commercially available
Drug: TMC125
200 mg twice daily until commercially available

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Experiencing Adverse Events
Time Frame: 1 week to 180 weeks, with a median of 62 weeks
The table below provides the number of participants who experienced Serious Adverse Events (SAEs) and Other Adverse Events (except SAEs) that started or worsened in severity during the overall TMC125-C217 treatment period. The duration of treatment ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.
1 week to 180 weeks, with a median of 62 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Participants With Virologic Outcomes Over Time
Time Frame: Weeks 24, 48, and 96
The table below shows the percentage of participants with virologic suppression (< 50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available over time (ie, at Weeks 24, 48, and 96).
Weeks 24, 48, and 96
Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)
Time Frame: Baseline, Week 24, Week 48, and Week 96
In the table below, the total number of participants analyzed in the Duet Placebo and Duet TMC125 groups, respectively at each time point were: Baseline (256;247 participants), Week 24 (251;240 participants), Week 48 (235;192 participants), and Week 96 (123;69 participants).
Baseline, Week 24, Week 48, and Week 96

Collaborators and Investigators

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

Sponsor

Tibotec Pharmaceuticals, Ireland

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

June 1, 2006

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002740
  • TMC125-C217 (Other Identifier: Tibotec Pharmaceuticals)
  • TMC125-C206 (Tibotec Pharmaceuticals)
  • TMC125-C216 (Tibotec Pharmaceuticals)

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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