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

NCT00359021 | Completed Phase 3 Results

• 4 other identifiers: CR002740TMC125-C217TMC125-C206TMC125-C216
• Study Type: interventional
• Target: 503
• Locations: 14 countries
• Sites: 72

Brief Summary

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.

Conditions

HIV-1

Keywords

HIV-1; treatment experienced; virologic failure

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Experiencing Adverse Events

  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 Outcomes (2)

• The Percentage of Participants With Virologic Outcomes Over Time

  Weeks 24, 48, and 96

• Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)

  Baseline, Week 24, Week 48, and Week 96

Study Arms (1)

001

EXPERIMENTAL

TMC125 200 mg twice daily until commercially available

Drug: TMC125

Interventions

TMC125 DRUG

200 mg twice daily until commercially available

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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• Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials because of any of the mandatory withdrawal criteria of that trial.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (72)

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Palm Springs, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Fort Laudersale, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Safety Harbor, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Camden, New Jersey, United States

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Newark, New Jersey, United States

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New York, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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Annandale, Virginia, United States

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Seattle, Washington, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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Neuquén, Argentina

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San Juan Bautista, Argentina

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Darlinghurst, Australia

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Antwerp, Belgium

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Liège, Belgium

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Curitiba, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Toronto, Canada

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Providencia, Chile

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Santiago, Chile

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Bordeaux, France

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Le Kremlin-Bicêtre, France

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Lyon, France

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Marseille, France

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Paris, France

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Rennes, France

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Toulouse, France

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Tourcoing, France

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Villejuif, France

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Berlin, Germany

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Essen, Germany

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Hamburg, Germany

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Mannheim, Germany

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München, Germany

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Mex Ctity, Mexico

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Mexico City, Mexico

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Panama City, Panama

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San Juan, Puerto Rico

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Barcelona, Spain

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Madrid, Spain

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Valencia, Spain

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Bangkok, Thailand

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Khon Kaen, Thailand

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MeSH Terms

Interventions

etravirine

Results Point of Contact

• Title: SENIOR DIRECTOR R&D
• Organization: Tibotec

1 609 730-7548

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 16, 2014
• Results First Posted: March 7, 2013

Record last verified: 2014-05

Locations

AR (4); ES (3); ME (2); US (32); TH (2); PR (1); CL (2); AU (1); DE (5); CA (4); FR (9); PA (1); BR (4); BE (2)