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AzTrials

HIVPhase 3NCT00254046

TMC125-C206: 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 at 55 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
616 participants
Where
55 sitesin 10 countries
Study dates
Nov 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 by having at least 1 NNRTI (non-nucleoside reverse transcriptase inhibitors) 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

Trial locations and contacts

55 sites in 10 countries.

55 sites in 10 countries

United States32 sites

  • Study site

    Annandale, Virginia

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Beverly Hills, California

  • Study site

    Boston, Massachusetts

  • Study site

    Dallas, Texas

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Galveston, Texas

  • Study site

    Houston, Texas

  • Study site

    Huntersville, North Carolina

  • Study site

    Little Rock, Arkansas

  • Study site

    Longview, Texas

  • Study site

    Los Angeles, California

  • Study site

    Macon, Georgia

  • Study site

    Miami, Florida

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    North Miami Beach, Florida

  • Study site

    Pensacola, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Safety Harbor, Florida

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Santa Fe, New Mexico

  • Study site

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Study site

    Vero Beach, Florida

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Argentina4 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Neuquén

  • Study site

    San Juan Bautista

Other trials in Argentina

Brazil4 sites

  • Study site

    Curitiba

  • Study site

    Rio de Janeiro

  • Study site

    Salvador

  • Study site

    São Paulo

Other trials in Brazil

France4 sites

  • Study site

    Bordeaux

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Paris

Other trials in France

Mexico3 sites

  • Study site

    Guadalajara

  • Study site

    Mex Ctity

  • Study site

    Mexico City

Other trials in Mexico

Chile2 sites

  • Study site

    Providencia

  • Study site

    Santiago

Other trials in Chile

Puerto Rico2 sites

  • Study site

    San Juan

  • Study site

    San Juan Pr

Other trials in Puerto Rico

Thailand2 sites

  • Study site

    Bangkok

  • Study site

    Khon Kaen

Other trials in Thailand

Costa Rica1 site

  • Study site

    San José

Other trials in Costa Rica

Panama1 site

  • Study site

    Panama City

Other trials in Panama

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 assessment 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 X100 mg tablets b.i.d.96 weeks

  • PlaceboDrug

    2 tablets b.i.d.96 weeks

Study groups in NCT00254046
Study groupRoleWhat they receive
002Placebo comparatorPlacebo 2 tablets b.i.d.96 weeks
Receives: Drug: Placebo
001Active comparatorTMC125 2 X100 mg tablets b.i.d.96 weeks
Receives: Drug: TMC125

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionFeb 2007
  4. Study completionJul 2008

Resources

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
616 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00254046
Sponsor's protocol ID
CR002752
Other IDs
TMC125-C206
Status last verified
Jun 2014
First submitted
10 Nov 2005
Last updated
20 Jun 2014
Results posted
No
Data monitoring committee
Yes

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 19710593

  • Kakuda 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 20881958

  • Clotet 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 20801782

  • Vingerhoets 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 20507207

  • Madruga JV, Cahn P, Grinsztejn B, Haubrich R, Lalezari J, Mills A, Pialoux G, Wilkin T, Peeters M, Vingerhoets J, de Smedt G, Leopold L, Trefiglio R, Woodfall B; DUET-1 study group. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007 Jul 7;370(9581):29-38. doi: 10.1016/S0140-6736(07)61047-2.

    PubMed 17617270

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 at 55 sites in 10 countries.

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 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Argentina, Brazil, France, Mexico and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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. (time frame: 24 weeks). 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 NCT00254046, 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 20 Jun 2014.

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