HIVPhase 3NCT00255099
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.
A Phase 3 study testing TMC125 in people with HIV, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- TMC125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 593 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jul 2008
- Phase
- Phase 3
- 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
- Patient has 3 or more primary protease inhibitor mutations
- documented genotypic evidence of resistance to currently available NNRTIs (non-nucleoside reverse transcriptase inhibitors) by having at least 1 NNRTI resistance-associated mutation
- on a stable antiretroviral therapy for at least 8 weeks
- plasma viral load at screening visit > 5000 HIV-1 RNA copies/mL.
Who cannot join
- Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)
- Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
- Use of disallowed concurrent therapy
- Any active clinically significant disease
About this study
Official title: A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.
The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used
Read the detailed description
This is a Phase III, randomized, double-blind, placebo-controlled trial to evaluate the long-term efficacy, tolerability, and safety of TMC125 as part of an antiretroviral therapy (ART) regimen containing TMC114/ritonavir (RTV) and an investigator-selected optimized background (OBR) in treatment-experienced HIV-1 infected patients. TMC125 is a non-nucleoside reverse transcriptase inhibitor (NNRTI). TMC114 is a protease inhibitor (PI). In this trial, TMC114 will be given with a low dose of ritonavir (RTV), a protease inhibitor commonly used with other, full dose protease inhibitors to improve activity. Additional assessments to be evaluated in this trial include: changes in the HIV-1 genotype, drug susceptibility, and the population pharmacokinetics of TMC125. A pharmacokinetic substudy will be performed at selected sites. Health-related quality of life will be assessed for patients receiving an antiretroviral therapy containing either TMC125 or placebo. Safety and tolerability will be documented throughout the trial. Six hundred HIV-1 infected patients on a stable but virologically failing regimen will be included in the trial. Patients should have at least 1 documented non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation (either at screening or from historical genotype reports), an HIV-1 plasma viral load > 5000 RNA copies/mL at screening, and at least 3 documented primary protease inhibitor (PI) mutations. Patients will be randomized in a 1:1 ratio to either TMC125 (200 mg twice daily) or to matching placebo; both in combination with TMC114/RTV (600/100 mg twice daily) and an investigator selected OBR of at least 2 antiretrovirals (ARVs), consisting of nucleoside reverse transcriptase inhibitor(s) (NRTI[s]) with or without enfuvirtide. The trial will involve a screening period of up to 6 weeks, a 48-week treatment period, and a 4 week follow-up period. Patients will take 200 mg oral doses of TMC125 tablets or placebo tablets, twice daily (administered as 2 tablets twice daily, with food) in combination with 600 mg oral doses of TMC114 tablets and 100 mg oral doses of ritonavir (administered as 2 tablets of TMC114 and 1 capsule of ritonavir twice daily, with food). The treatment period is 48 weeks.
- Conditions
- HIV
- Being tested
- TMC125, Placebo
- Keywords
- HIV, HIV-1, TMC125
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC125Drug
2 x 100 mg tablets b.i.d. / 96 weeks
PlaceboDrug
2 tablets b.i.d. / 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| 001 | Active comparator | TMC125 2 x 100 mg tablets b.i.d. / 96 weeks Receives: Drug: TMC125 |
| 002 | Placebo comparator | Placebo 2 tablets b.i.d. / 96 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 593 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
- NCT00255099
- Sponsor's protocol ID
- CR006307
- Other IDs
- TMC125-C216
- Status last verified
- Jun 2011
- First submitted
- 15 Nov 2005
- Last updated
- 15 Jun 2011
- Results posted
- No
Publications
Katlama C, Haubrich R, Lalezari J, Lazzarin A, Madruga JV, Molina JM, Schechter M, Peeters M, Picchio G, Vingerhoets J, Woodfall B, De Smedt G; DUET-1, DUET-2 study groups. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009 Nov 13;23(17):2289-300. doi: 10.1097/QAD.0b013e3283316a5e.
PubMed 19710593Kakuda TN, Wade JR, Snoeck E, Vis P, Scholler-Gyure M, Peeters MP, Corbett C, Nijs S, Vingerhoets J, Leopold L, De Smedt G, Woodfall BJ, Hoetelmans RM. Pharmacokinetics and pharmacodynamics of the non-nucleoside reverse-transcriptase inhibitor etravirine in treatment-experienced HIV-1-infected patients. Clin Pharmacol Ther. 2010 Nov;88(5):695-703. doi: 10.1038/clpt.2010.181. Epub 2010 Sep 29.
PubMed 20881958Clotet B, Clumeck N, Katlama C, Nijs S, Witek J. Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: pooled 96 week results from the Phase III DUET trials. J Antimicrob Chemother. 2010 Nov;65(11):2450-4. doi: 10.1093/jac/dkq332. Epub 2010 Aug 27.
PubMed 20801782Vingerhoets J, Azijn H, Tambuyzer L, Dierynck I, De Meyer S, Rimsky L, Nijs S, De Smedt G, de Bethune MP, Picchio G. Short communication: activity of etravirine on different HIV type 1 subtypes: in vitro susceptibility in treatment-naive patients and week 48 pooled DUET study data. AIDS Res Hum Retroviruses. 2010 Jun;26(6):621-4. doi: 10.1089/aid.2009.0239.
PubMed 20507207Lazzarin A, Campbell T, Clotet B, Johnson M, Katlama C, Moll A, Towner W, Trottier B, Peeters M, Vingerhoets J, de Smedt G, Baeten B, Beets G, Sinha R, Woodfall B; DUET-2 study group. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007 Jul 7;370(9581):39-48. doi: 10.1016/S0140-6736(07)61048-4.
PubMed 17617271
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.
- ClinicalTrials.gov ID
- NCT00255099
- Acronym / sponsor ID
- CR006307
- Conditions
- HIV
- Keywords
- HIV, HIV-1, TMC125
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Nov 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.
The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used
Detailed description
This is a Phase III, randomized, double-blind, placebo-controlled trial to evaluate the long-term efficacy, tolerability, and safety of TMC125 as part of an antiretroviral therapy (ART) regimen containing TMC114/ritonavir (RTV) and an investigator-selected optimized background (OBR) in treatment-experienced HIV-1 infected patients. TMC125 is a non-nucleoside reverse transcriptase inhibitor (NNRTI). TMC114 is a protease inhibitor (PI). In this trial, TMC114 will be given with a low dose of ritonavir (RTV), a protease inhibitor commonly used with other, full dose protease inhibitors to improve activity. Additional assessments to be evaluated in this trial include: changes in the HIV-1 genotype, drug susceptibility, and the population pharmacokinetics of TMC125. A pharmacokinetic substudy will be performed at selected sites. Health-related quality of life will be assessed for patients receiving an antiretroviral therapy containing either TMC125 or placebo. Safety and tolerability will be documented throughout the trial. Six hundred HIV-1 infected patients on a stable but virologically failing regimen will be included in the trial. Patients should have at least 1 documented non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation (either at screening or from historical genotype reports), an HIV-1 plasma viral load > 5000 RNA copies/mL at screening, and at least 3 documented primary protease inhibitor (PI) mutations. Patients will be randomized in a 1:1 ratio to either TMC125 (200 mg twice daily) or to matching placebo; both in combination with TMC114/RTV (600/100 mg twice daily) and an investigator selected OBR of at least 2 antiretrovirals (ARVs), consisting of nucleoside reverse transcriptase inhibitor(s) (NRTI[s]) with or without enfuvirtide. The trial will involve a screening period of up to 6 weeks, a 48-week treatment period, and a 4 week follow-up period. Patients will take 200 mg oral doses of TMC125 tablets or placebo tablets, twice daily (administered as 2 tablets twice daily, with food) in combination with 600 mg oral doses of TMC114 tablets and 100 mg oral doses of ritonavir (administered as 2 tablets of TMC114 and 1 capsule of ritonavir twice daily, with food). The treatment period is 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Active comparator | Drug: TMC125TMC125 2 x 100 mg tablets b.i.d. / 96 weeks |
| 002 | Placebo comparator | Drug: PlaceboPlacebo 2 tablets b.i.d. / 96 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has 3 or more primary protease inhibitor mutations
- documented genotypic evidence of resistance to currently available NNRTIs (non-nucleoside reverse transcriptase inhibitors) by having at least 1 NNRTI resistance-associated mutation
- on a stable antiretroviral therapy for at least 8 weeks
- plasma viral load at screening visit > 5000 HIV-1 RNA copies/mL.
Key exclusion criteria (4 listed)
- Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)
- Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
- Use of disallowed concurrent therapy
- Any active clinically significant disease
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 |
|---|---|---|
| TMC1252 x 100 mg tablets b.i.d. / 96 weeks | Drug | 001 |
| Placebo2 tablets b.i.d. / 96 weeks | Drug | 002 |
Primary outcome
Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen.
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 15 Jun 2011.
- Results publication: PubMed 19710593Katlama C, Haubrich R, Lalezari J, Lazzarin A, Madruga JV, Molina JM, Schechter M, Peeters M, Picchio G, Vingerhoets J, Woodfall B, De Smedt G; DUET-1, DUET-2 study groups. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009 Nov 13;23(17):2289-300. doi: 10.1097/QAD.0b013e3283316a5e.
- Derived from this study: PubMed 20881958Kakuda TN, Wade JR, Snoeck E, Vis P, Scholler-Gyure M, Peeters MP, Corbett C, Nijs S, Vingerhoets J, Leopold L, De Smedt G, Woodfall BJ, Hoetelmans RM. Pharmacokinetics and pharmacodynamics of the non-nucleoside reverse-transcriptase inhibitor etravirine in treatment-experienced HIV-1-infected patients. Clin Pharmacol Ther. 2010 Nov;88(5):695-703. doi: 10.1038/clpt.2010.181. Epub 2010 Sep 29.
- Derived from this study: PubMed 20801782Clotet B, Clumeck N, Katlama C, Nijs S, Witek J. Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: pooled 96 week results from the Phase III DUET trials. J Antimicrob Chemother. 2010 Nov;65(11):2450-4. doi: 10.1093/jac/dkq332. Epub 2010 Aug 27.
- Derived from this study: PubMed 20507207Vingerhoets J, Azijn H, Tambuyzer L, Dierynck I, De Meyer S, Rimsky L, Nijs S, De Smedt G, de Bethune MP, Picchio G. Short communication: activity of etravirine on different HIV type 1 subtypes: in vitro susceptibility in treatment-naive patients and week 48 pooled DUET study data. AIDS Res Hum Retroviruses. 2010 Jun;26(6):621-4. doi: 10.1089/aid.2009.0239.
- Derived from this study: PubMed 17617271Lazzarin A, Campbell T, Clotet B, Johnson M, Katlama C, Moll A, Towner W, Trottier B, Peeters M, Vingerhoets J, de Smedt G, Baeten B, Beets G, Sinha R, Woodfall B; DUET-2 study group. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007 Jul 7;370(9581):39-48. doi: 10.1016/S0140-6736(07)61048-4.
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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 3 study testing TMC125 in people with HIV, 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 4 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 15 Jun 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen.. 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 NCT00255099, which also lists 5 linked publications.
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 15 Jun 2011.