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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254046
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : June 20, 2014
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Drug: TMC125 Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Etravirine

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254046

  Hide Study Locations
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Beverly Hills, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, District of Columbia
Washington, District of Columbia, United States
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
United States, Georgia
Atlanta, Georgia, United States
Macon, Georgia, United States
United States, Kansas
Wichita, Kansas, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New Jersey
Newark, New Jersey, United States
United States, New Mexico
Santa Fe, New Mexico, United States
United States, New York
Bronx, New York, United States
New York, New York, United States
United States, North Carolina
Huntersville, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
United States, Virginia
Annandale, Virginia, United States
Buenos Aires, Argentina
Cordoba, Argentina
Florencio Varela, Argentina
Neuquen, Argentina
Curitiba, Brazil
Rio De Janeiro, Brazil
Salvador, Brazil
Sao Paulo, Brazil
Providencia, Chile
Santiago, Chile
Costa Rica
San Jose, Costa Rica
Bordeaux Cedex, France
Bordeaux N/A, France
Lyon, France
Marseille Cedex 09, France
Paris, France
Ciudad De Mexico, Mexico
Guadalajara, Mexico
Mex Ctity, Mexico
Panama, Panama
Puerto Rico
San Juan Pr, Puerto Rico
San Juan, Puerto Rico
Bangkok, Thailand
Khon Kaen, Thailand
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tibotec Pharmaceuticals, Ireland Identifier: NCT00254046     History of Changes
Other Study ID Numbers: CR002752
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014

Keywords provided by Tibotec Pharmaceuticals, Ireland:

Additional relevant MeSH terms:
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors