HIV InfectionPhase 2NCT00111280
TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial
A Phase 2 study testing TMC125 in people with HIV Infection, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
This is a Phase II, open-label, roll-over trial to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects. 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
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Mar 2007
- 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
- Subject has signed the Informed Consent Form (ICF) voluntarily
- Male or female subject, aged 18 years and above
- Subject having previously been randomized to an active control arm of a sponsor selected TMC125 trial and has completed the entire treatment period or has met the definition of virological failure, as defined in the original protocol, before TMC125 C211 screening or subjects who were randomized in a fully blinded TMC125 trial, being unblinded after treatment for at least 48 weeks and identified as having received placebo
- Subject agrees to take TMC125 in combination with the investigator-selected combination therapy consisting of at least 2 drugs (NRTIs and/or allowed PI and/or T-20
- low-dose ritonavir [= 400 mg daily dose] is not counted as a separate ARV)
- Subject can comply with the protocol requirements
- Subject's general medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial
Who cannot join
- History of or currently active alcohol or substance use which in the investigator's opinion would likely compromise the subject's safety or compliance with the study procedures
- Any active clinically significant disease (e.g., tuberculosis, cardiac dysfunction) or findings during physical examination that, in the investigator's opinion, would compromise the subject's safety
- Renal impairment as defined by serum creatinine > 2 x upper limit of normal (ULN)
- Any grade 3 or grade 4 toxicity according to the AIDS Clinical Trial Group (ACTG) grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevations
- or asymptomatic and isolated grade 3 or 4 elevations in gamma-glutamyl transferase [GGT] with all other liver enzymes and bilirubin within normal ranges, or isolated grade 3 elevation in amylase with no increase in lipase and no history of pancreatitis)
- Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio > 1.3 or albumin < 30 g/l or direct bilirubin > 2.5 x ULN).
About this study
Official title: HIV-1 Infected Subjects Who Were Randomized in Any Sponsor-selected TMC125 Trial to an Active Control Arm and Either Virologically Failed or Completed the Entire Treatment Period, or to Placebo Arm and Were Treated for at Least 48 Weeks.
This is a Phase II, open-label, roll-over trial to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV phenotype and genotype will be evaluated.
Read the detailed description
The purpose of this Phase II, open-label, roll-over trial is to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV phenotype and genotype will be evaluated. Subjects who were randomized to an active control arm of any sponsor-selected TMC125 trial and virologically failed or completed the entire treatment period, or to placebo arm and were treated for at least 48 and who may derive benefit from TMC125 treatment as judged by the investigator can be enrolled. Based on the currently selected studies, a maximum of 170 subjects will be enrolled in the current trial. A dose of 800mg b.i.d . of TMC125 (formulation TF035) and after the formulation switch, 200mg b.i.d. (formulation F060), will be given in combination with an investigator-selected, optimized underlying therapy starting at baseline and consisting of at least 2 drugs (nucleoside reverse transcriptase inhibitors [NRTIs] and/or allowed protease inhibitors [PIs] and/or enfuvirtide [T 20]) for 48 weeks. Tolerability and safety will be assessed throughout the trial. The efficacy parameters will be determined at defined time points during the trial. The trial will involve a screening visit preferable on the same day as the withdrawal visit of the sponsor-selected trial, a baseline visit, a treatment period of 48 weeks, a final visit and a 4 week follow-up period. TMC125, 800 mg twice a day and after formulation switch, at 200 mg twice a day
- Conditions
- HIV Infection
- Being tested
- TMC125
- Keywords
- HIV infection, TMC125, Nucleoside reverse transcriptase inhibitors (NRTIs), roll-over trial, antiretrovirals (ARVs)
- 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 long-term safety and tolerability of TMC125.
Secondary outcomes (1)
The secondary objectives are to evaluate the antiviral activity and immunological effect of TMC125 as part of an antiretroviral (ARV) regimen over time, and to evaluate genotypic and phenotypic changes over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2005 (estimated)
- Study startSep 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT00111280
- Sponsor's protocol ID
- CR006742
- Status last verified
- Apr 2010
- First submitted
- 18 May 2005
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-1 Infected Subjects Who Were Randomized in Any Sponsor-selected TMC125 Trial to an Active Control Arm and Either Virologically Failed or Completed the Entire Treatment Period, or to Placebo Arm and Were Treated for at Least 48 Weeks.
- ClinicalTrials.gov ID
- NCT00111280
- Acronym / sponsor ID
- CR006742
- Conditions
- HIV Infection
- Keywords
- HIV infection, TMC125, Nucleoside reverse transcriptase inhibitors (NRTIs), roll-over trial, antiretrovirals (ARVs)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Mar 2007 (actual)
- First posted
- 19 May 2005 (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.
This is a Phase II, open-label, roll-over trial to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV phenotype and genotype will be evaluated.
Detailed description
The purpose of this Phase II, open-label, roll-over trial is to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects. In addition, the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time, and the evolution of HIV phenotype and genotype will be evaluated. Subjects who were randomized to an active control arm of any sponsor-selected TMC125 trial and virologically failed or completed the entire treatment period, or to placebo arm and were treated for at least 48 and who may derive benefit from TMC125 treatment as judged by the investigator can be enrolled. Based on the currently selected studies, a maximum of 170 subjects will be enrolled in the current trial. A dose of 800mg b.i.d . of TMC125 (formulation TF035) and after the formulation switch, 200mg b.i.d. (formulation F060), will be given in combination with an investigator-selected, optimized underlying therapy starting at baseline and consisting of at least 2 drugs (nucleoside reverse transcriptase inhibitors [NRTIs] and/or allowed protease inhibitors [PIs] and/or enfuvirtide [T 20]) for 48 weeks. Tolerability and safety will be assessed throughout the trial. The efficacy parameters will be determined at defined time points during the trial. The trial will involve a screening visit preferable on the same day as the withdrawal visit of the sponsor-selected trial, a baseline visit, a treatment period of 48 weeks, a final visit and a 4 week follow-up period. TMC125, 800 mg twice a day and after formulation switch, at 200 mg twice a day
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has signed the Informed Consent Form (ICF) voluntarily
- Male or female subject, aged 18 years and above
- Subject having previously been randomized to an active control arm of a sponsor selected TMC125 trial and has completed the entire treatment period or has met the definition of virological failure, as defined in the original protocol, before TMC125 C211 screening or subjects who were randomized in a fully blinded TMC125 trial, being unblinded after treatment for at least 48 weeks and identified as having received placebo
- Subject agrees to take TMC125 in combination with the investigator-selected combination therapy consisting of at least 2 drugs (NRTIs and/or allowed PI and/or T-20
- low-dose ritonavir [= 400 mg daily dose] is not counted as a separate ARV)
Key exclusion criteria (6 listed)
- History of or currently active alcohol or substance use which in the investigator's opinion would likely compromise the subject's safety or compliance with the study procedures
- Any active clinically significant disease (e.g., tuberculosis, cardiac dysfunction) or findings during physical examination that, in the investigator's opinion, would compromise the subject's safety
- Renal impairment as defined by serum creatinine > 2 x upper limit of normal (ULN)
- Any grade 3 or grade 4 toxicity according to the AIDS Clinical Trial Group (ACTG) grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevations
- or asymptomatic and isolated grade 3 or 4 elevations in gamma-glutamyl transferase [GGT] with all other liver enzymes and bilirubin within normal ranges, or isolated grade 3 elevation in amylase with no increase in lipase and no history of pancreatitis)
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 long-term safety and tolerability of TMC125.
1 secondary outcome
The secondary objectives are to evaluate the antiviral activity and immunological effect of TMC125 as part of an antiretroviral (ARV) regimen over time, and to evaluate genotypic and phenotypic changes over time.
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 19 May 2011.
- Clinical Study Report Synopsis of TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial.Link provided by the sponsor.
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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 7 inclusion and 6 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 19 May 2011. 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 long-term safety and tolerability of TMC125.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2011.