TMC125-C206: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.

June 19, 2014 updated by: Tibotec Pharmaceuticals, Ireland

A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.

The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III, randomized, double-blind, placebo-controlled trial to evaluate the long-term efficacy, tolerability, and safety of TMC125 as part of an antiretroviral therapy (ART) regimen containing TMC114/ritonavir (RTV) and an investigator-selected optimized background (OBR) in treatment-experienced HIV-1 infected patients. TMC125 is a non-nucleoside reverse transcriptase inhibitor (NNRTI). TMC114 is a protease inhibitor (PI). In this trial, TMC114 will be given with a low dose of ritonavir (RTV), a protease inhibitor commonly used with other, full dose protease inhibitors to improve activity. Additional assessment to be evaluated in this trial include: changes in the HIV-1 genotype, drug susceptibility, and the population pharmacokinetics of TMC125. A pharmacokinetic substudy will be performed at selected sites. Health-related quality of life will be assessed for patients receiving an antiretroviral therapy containing either TMC125 or placebo. Safety and tolerability will be documented throughout the trial. Six hundred HIV-1 infected patients on a stable but virologically failing regimen will be included in the trial. Patients should have at least 1 documented non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation (either at screening or from historical genotype reports), an HIV-1 plasma viral load > 5000 RNA copies/mL at screening, and at least 3 documented primary protease inhibitor (PI) mutations. Patients will be randomized in a 1:1 ratio to either TMC125 (200 mg twice daily) or to matching placebo; both in combination with TMC114/RTV (600/100 mg twice daily) and an investigator selected OBR of at least 2 antiretrovirals (ARVs), consisting of nucleoside reverse transcriptase inhibitor(s) (NRTI[s]) with or without enfuvirtide. The trial will involve a screening period of up to 6 weeks, a 48-week treatment period, and a 4-week follow-up period. Patients will take 200 mg oral doses of TMC125 tablets or placebo tablets; twice daily (administered as 2 tablets twice daily, with food) in combination with 600 mg oral doses of TMC114 tablets and 100 mg oral doses of ritonavir (administered as 2 tablets of TMC114 and 1 capsule of ritonavir twice daily, with food). The treatment period is 48 weeks.

Study Type

Interventional

Enrollment (Actual)

616

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
  • Brazil
      • Curitiba, Brazil
      • Rio De Janeiro, Brazil
      • Salvador, Brazil
      • Sao Paulo, Brazil
  • Chile
      • Providencia, Chile
      • Santiago, Chile
  • Costa Rica
      • San Jose, Costa Rica
  • France
      • Bordeaux Cedex, France
      • Bordeaux N/A, France
      • Lyon, France
      • Marseille Cedex 09, France
      • Paris, France
  • Mexico
      • Ciudad De Mexico, Mexico
      • Guadalajara, Mexico
      • Mex Ctity, Mexico
  • Panama
      • Panama, Panama
  • Puerto Rico
      • San Juan, Puerto Rico
      • San Juan Pr, Puerto Rico
  • Thailand
      • Bangkok, Thailand
      • Khon Kaen, Thailand
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Beverly Hills, California, United States
      • Los Angeles, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Ft Lauderdale, Florida, United States
      • Miami, Florida, United States
      • N Miami Beach, Florida, United States
      • Pensacola, Florida, United States
      • Safety Harbor, Florida, United States
      • Tampa, Florida, United States
      • Vero Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Macon, Georgia, United States
    • Kansas
      • Wichita, Kansas, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • New Jersey
      • Newark, New Jersey, United States
    • New Mexico
      • Santa Fe, New Mexico, United States
    • New York
      • Bronx, New York, United States
      • New York, New York, United States
    • North Carolina
      • Huntersville, 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
      • Galveston, Texas, United States
      • Houston, Texas, United States
      • Longview, Texas, United States
    • Virginia
      • Annandale, Virginia, 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 has 3 or more primary protease inhibitor mutations
  • documented genotypic evidence of resistance to currently available NNRTIs by having at least 1 NNRTI (non-nucleoside reverse transcriptase inhibitors) resistance-associated mutation
  • on a stable antiretroviral therapy for at least 8 weeks
  • plasma viral load at screening visit > 5000 HIV-1 RNA copies/mL.

Exclusion Criteria:

  • Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)
  • Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
  • Use of disallowed concurrent therapy
  • Any active clinically significant disease

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 002
Placebo 2 tablets b.i.d.96 weeks
Drug: Placebo
2 tablets b.i.d.96 weeks
Active Comparator: 001
TMC125 2 X100 mg tablets b.i.d.96 weeks
Drug: TMC125
2 X100 mg tablets b.i.d.96 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen.
Time Frame: 24 weeks
24 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

Helpful Links

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, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 10, 2005

First Posted (Estimate)

November 15, 2005

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

  • CR002752
  • TMC125-C206 (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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