- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00081978
TMC125-C223: TMC125 in HIV-1 Infected Subjects
April 26, 2010 updated by: Tibotec Pharmaceuticals, Ireland
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
211
Phase
- Phase 2
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:
- 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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Evaluate the antiviral activity, safety and tolerability of TMC125, immunologic changes, changes in viral genotype and drug suseptibility, PK of TMC125 and compare antiviral effect among treatment groups
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
March 1, 2004
Study Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
April 28, 2004
First Submitted That Met QC Criteria
April 29, 2004
First Posted (Estimate)
April 30, 2004
Study Record Updates
Last Update Posted (Estimate)
April 28, 2010
Last Update Submitted That Met QC Criteria
April 26, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Etravirine
Other Study ID Numbers
- CR006736
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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