TMC125-C223: TMC125 in HIV-1 Infected Subjects - Full Text View

Sponsored by:	Tibotec Pharmaceutical Limited
Information provided by:	Tibotec Pharmaceutical Limited
ClinicalTrials.gov Identifier:	NCT00081978

Purpose

The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily for 48 weeks.

Condition	Intervention	Phase
HIV Infection	Drug: TMC125	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Safety/Efficacy Study
Official Title:	A Randomized, Controlled, Partially Blinded Phase IIb Dose-Finding Trial of TMC125 in HIV-1 Infected Subjects With Documented Genotypic Evidence of Resistance to Currently Available NNRTIs and With at Least Three Primary PI Mutations

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Etravirine

U.S. FDA Resources

Further study details as provided by Tibotec Pharmaceutical Limited:

Primary Outcome Measures:

The primary objective of the trial is to evaluate the dose-response relationship of antiviral activity at 24 weeks within the two TMC125 dose regimens.

Secondary Outcome Measures:

Evaluate the antiviral activity, safety and tolerability of TMC125, immunologic changes, changes in viral genotype and drug susceptibility, PK of TMC125 and compare antiviral effect among treatment groups

Enrollment:	211
Study Start Date:	March 2004
Study Completion Date:	October 2005

Detailed Description:

TMC125 will be given in addition to a combination of anti-HIV drugs that have been selected specifically for you by your doctor. There are three treatment groups in the study. One group will be given a dosage of TMC125, 400 mg twice daily. Another will be given 800 mg twice daily. The third group, a control arm, will not receive TMC125 (formulation TF035). The safety, tolerability and pharmacokinetics (determinations of the concentration of drug in your blood and its evolution over time) of TMC125 will also be evaluated in this study. Patients who have known resistance to NNRTIs and 3 or more protease inhibitor (PI) mutations may be eligible to participate.

One-hundred-fifty (150) patients will be enrolled into this study. TMC125, 400mg twice daily for 48 weeks; TMC125, 800mg twice daily for 48 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 plasma viral load at screening >1000 copies/ml
Documented genotypic evidence of resistance to currently available NNRTIs
Previous NRTI experience for at least 3 months
3 primary PI mutations at screening

Exclusion Criteria:

Chronic HBV and/or HCV with elevated liver function tests > 3x upper normal limits
Any grade 3 or 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevation)
Previous permanent discontinuation of any NNRTI due to cutaneous events.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081978

Sponsors and Collaborators

Tibotec Pharmaceutical Limited

Investigators

Study Director:

Tibotec Clinical Trial

Tibotec Pharmaceutical Limited

More Information

Publications:

Cohen CJ, Berger DS, Blick G, Grossman HA, Jayaweera DT, Shalit P, Thompson M, Peeters M, de Béthune MP, Voorspoels E, Mack R, Woodfall B. Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial. AIDS. 2009 Jan 28;23(3):423-6.

Study ID Numbers:	CR006736
Study First Received:	April 28, 2004
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00081978 History of Changes
Health Authority:	United States: Food and Drug Administration; Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceutical Limited:

HIV infection
TMC125
Non-nucleoside reverse transcriptase inhibitor, TMC125-C223

Study placed in the following topic categories:

Virus Diseases
Anti-Infective Agents
Signs and Symptoms
Sexually Transmitted Diseases, Viral
Anti-Retroviral Agents
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Antiviral Agents
Retroviridae Infections
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 10, 2009