TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

July 1, 2015 updated by: Tibotec Pharmaceuticals, Ireland

A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients

Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIV(viral load) in the blood. People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both. The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir. Kaletra (LPV/RTV) is either a tablet or capsule taken twice a day. The oral capsule contains 133.3 mg LPV, 33.3 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra.

Study Type

Interventional

Enrollment (Actual)

604

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
      • Rosario, Argentina
  • Australia
      • Darlinghurst, Australia
      • Melbourne, Australia
      • Perth, Australia
      • Surry Hills, Australia
  • Austria
      • Wien, Austria
      • Wien N/A, Austria
  • Belgium
      • Antwerpen, Belgium
      • Brussels, Belgium
  • Brazil
      • Curitiba, Brazil
      • Distrito Barao Geraldo-Campina, Brazil
      • Nova Iguacu, Brazil
      • Pinheiros, Brazil
      • Rio De Janeiro, Brazil
      • Sao Paulo, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Chile
      • Providencia, Chile
      • Santiago, Chile
  • Denmark
      • Aalborg, Denmark
  • France
      • Nice, France
      • Paris, France
      • Paris Cedex 10, France
      • Paris Cedex 12, France
      • Rennes, France
      • Villejuif Cedex, France
  • Germany
      • Aachen, Germany
      • Berlin, Germany
      • Düsseldorf, Germany
      • Hamburg, Germany
      • Köln, Germany
      • Mannheim, Germany
      • Osnabrück, Germany
      • Stuttgart, Germany
  • Greece
      • Melissia-Athens, Greece
  • Guatemala
      • Guatemala, Guatemala
  • Hungary
      • Budapest, Hungary
  • Malaysia
      • Kuala Lumpur, Malaysia
      • Sungai Buloh, Malaysia
  • Mexico
      • Guadalajara, Mexico
  • Netherlands
      • Amsterdam, Netherlands
      • Groningen, Netherlands
      • Rotterdam, Netherlands
  • Panama
      • Panama, Panama
  • Portugal
      • Lisboa, Portugal
      • Porto, Portugal
  • Puerto Rico
      • San Juan, Puerto Rico
  • Russian Federation
      • Kazan, Russian Federation
      • Moscow N/A, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Saint-Petersburg, Russian Federation
      • St Petersburg, Russian Federation
      • Volgograd, Russian Federation
  • South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Houghton, Johannesburg, South Africa
      • Johannesburg, South Africa
      • Pretoria, South Africa
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
  • Switzerland
      • Zurich N/A, Switzerland
  • Thailand
      • Bangkok, Thailand
      • Khon Kaen, Thailand
  • United Kingdom
      • London, United Kingdom
  • 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
      • San Francisco, California, United States
      • West Hollywood, California, United States
    • Colorado
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Ft Lauderdale, Florida, United States
      • Miami, Florida, United States
      • Orlando, 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
    • Illinois
      • Chicago, Illinois, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Berkley, Michigan, United States
    • New Jersey
      • Camden, New Jersey, United States
      • East Orange, New Jersey, United States
      • Newark, New Jersey, United States
    • New York
      • Bronx, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Huntersville, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Galveston, Texas, United States
      • Houston, Texas, United States
      • Longview, Texas, United States
    • Virginia
      • Hampton, Virginia, 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:

  • Patient has documented HIV-1 infection
  • Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks
  • Plasma HIV-1 RNA >1000 copies/mL
  • General medical condition does not interfere with the assessments and the completion of the trial

Exclusion Criteria:

  • Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
  • tenofovir, emtricitabine, atazanavir, fosamprenavir
  • Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114
  • Life expectancy of less than 6 months
  • Pregnant or breast-feeding
  • Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period
  • Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels
  • Participation in other investigational trials without prior approval of the sponsor

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 002
LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV
Drug: LPV/rtv
One 400mg LPV tablet twice daily with 100mg RTV
Experimental: 001
TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV
Drug: TMC114/rtv
Two 300mg TMC114 tablets twice daily with 100mg RTV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: 96 weeks
96 weeks
Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)
Time Frame: 96 Weeks
96 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

April 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

May 13, 2005

First Submitted That Met QC Criteria

May 13, 2005

First Posted (Estimate)

May 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002794
  • TMC114-C214 (Other Identifier: Tibotec Pharmaceuticals, Ireland)

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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