HIV InfectionPhase 2NCT00081978
TMC125-C223: TMC125 in HIV-1 Infected Subjects
A Phase 2 study testing TMC125 in people with HIV Infection, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- TMC125
- How many people
- 211 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this 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
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.
Read the 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.
- Conditions
- HIV Infection
- Being tested
- TMC125
- Keywords
- HIV infection, TMC125, Non-nucleoside reverse transcriptase inhibitor, TMC125-C223
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC125Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2004 (estimated)
- Study startMar 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tibotec Pharmaceuticals Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081978
- Sponsor's protocol ID
- CR006736
- Status last verified
- Apr 2010
- First submitted
- 28 Apr 2004
- Last updated
- 28 Apr 2010
- Results posted
- No
Publications
Cohen CJ, Berger DS, Blick G, Grossman HA, Jayaweera DT, Shalit P, Thompson M, Peeters M, de Bethune 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. doi: 10.1097/QAD.0b013e32831c5040.
PubMed 19114852
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00081978
- Acronym / sponsor ID
- CR006736
- Conditions
- HIV Infection
- Keywords
- HIV infection, TMC125, Non-nucleoside reverse transcriptase inhibitor, TMC125-C223
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 30 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMC125 | Drug | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
- Results publication: PubMed 19114852Cohen CJ, Berger DS, Blick G, Grossman HA, Jayaweera DT, Shalit P, Thompson M, Peeters M, de Bethune 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. doi: 10.1097/QAD.0b013e32831c5040.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibotec Pharmaceuticals Clinical Trial study director
Tibotec Pharmaceutical Limited
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMC125 in people with HIV Infection, run by Tibotec Pharmaceuticals, Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00081978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2010.