MedDataX Logo

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

NCT ID: NCT00359021

Last Updated: 2014-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial

NCT00111280

HIV Infection
COMPLETED PHASE2

TMC125-C216: 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.

NCT00255099

HIV
COMPLETED PHASE3

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.

NCT00254046

HIV
COMPLETED PHASE3

TMC125-C223: TMC125 in HIV-1 Infected Subjects

NCT00081978

HIV Infection
COMPLETED PHASE2

TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use

NCT00225303

HIV Infection
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

001

TMC125 200 mg twice daily until commercially available

Group Type EXPERIMENTAL

TMC125

Intervention Type DRUG

200 mg twice daily until commercially available

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TMC125

200 mg twice daily until commercially available

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tibotec Pharmaceuticals, Ireland

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tibotec Pharmaceuticals Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceutical Limited

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phoenix, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Beverly Hills, California, United States

Site Status

Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Palm Springs, California, United States

Site Status

San Diego, California, United States

Site Status

San Francisco, California, United States

Site Status

Denver, Colorado, United States

Site Status

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

Site Status

Fort Lauderdale, Florida, United States

Site Status

Fort Laudersale, Florida, United States

Site Status

Miami, Florida, United States

Site Status

North Miami Beach, Florida, United States

Site Status

Safety Harbor, Florida, United States

Site Status

Tampa, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

Camden, New Jersey, United States

Site Status

Newark, New Jersey, United States

Site Status

New York, New York, United States

Site Status

The Bronx, New York, United States

Site Status

Durham, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Portland, Oregon, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Austin, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Longview, Texas, United States

Site Status

Annandale, Virginia, United States

Site Status

Seattle, Washington, United States

Site Status

Buenos Aires, , Argentina

Site Status

Córdoba, , Argentina

Site Status

Neuquén, , Argentina

Site Status

San Juan Bautista, , Argentina

Site Status

Darlinghurst, , Australia

Site Status

Antwerp, , Belgium

Site Status

Liège, , Belgium

Site Status

Curitiba, , Brazil

Site Status

Rio de Janeiro, , Brazil

Site Status

Salvador, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Calgary, Alberta, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Toronto, , Canada

Site Status

Providencia, , Chile

Site Status

Santiago, , Chile

Site Status

Bordeaux, , France

Site Status

Le Kremlin-Bicêtre, , France

Site Status

Lyon, , France

Site Status

Marseille, , France

Site Status

Paris, , France

Site Status

Rennes, , France

Site Status

Toulouse, , France

Site Status

Tourcoing, , France

Site Status

Villejuif, , France

Site Status

Berlin, , Germany

Site Status

Essen, , Germany

Site Status

Hamburg, , Germany

Site Status

Mannheim, , Germany

Site Status

München, , Germany

Site Status

Mex Ctity, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Panama City, , Panama

Site Status

San Juan, , Puerto Rico

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Valencia, , Spain

Site Status

Bangkok, , Thailand

Site Status

Khon Kaen, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Brazil Canada Chile France Germany Mexico Panama Puerto Rico Spain Thailand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TMC125-C217

Identifier Type: OTHER

Identifier Source: secondary_id

TMC125-C206

Identifier Type: OTHER

Identifier Source: secondary_id

TMC125-C216

Identifier Type: OTHER

Identifier Source: secondary_id

CR002740

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials
NCT02187107 COMPLETED PHASE2
An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
NCT00081588 COMPLETED PHASE2
A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study
NCT00128830 COMPLETED PHASE2
TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options
NCT00115050 COMPLETED PHASE3
TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients
NCT00412646 COMPLETED PHASE2
TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
NCT00245739 APPROVED_FOR_MARKETING
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
NCT00665847 COMPLETED PHASE2
TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously
NCT00513513 TERMINATED PHASE2
TMC114-C213: A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose-response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.
NCT00650832 COMPLETED PHASE2
A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents
NCT00355524 COMPLETED PHASE2
Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
NCT02603107 COMPLETED PHASE3
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
NCT05911360 ACTIVE_NOT_RECRUITING PHASE3
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
NCT00110305 COMPLETED PHASE2
A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
NCT00046176 COMPLETED PHASE3
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
NCT02120352 COMPLETED PHASE2
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection
NCT00127959 COMPLETED PHASE4
TMC114-C201: A Study to Determine the Antiviral Activity of TMC114 in Patients With Multiple Protease Inhibitor (PI) Resistant Human Immunodeficiency Virus (HIV) Strains
NCT00964327 COMPLETED PHASE2
Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
NCT00084253 COMPLETED PHASE4
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT05979311 ACTIVE_NOT_RECRUITING PHASE3
The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
NCT00001082 COMPLETED PHASE3
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
NCT00002419 COMPLETED PHASE2
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
NCT01737359 TERMINATED PHASE2
Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression
NCT00344981 COMPLETED NA
the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
NCT04041362 WITHDRAWN PHASE2
A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
NCT00242879 TERMINATED PHASE2