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 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.
2 other identifiers
interventional
616
10 countries
55
Brief 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. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv
Started Nov 2005
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJune 20, 2014
June 1, 2014
1.3 years
November 10, 2005
June 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
24 weeks
Study Arms (2)
002
PLACEBO COMPARATORPlacebo 2 tablets b.i.d.96 weeks
001
ACTIVE COMPARATORTMC125 2 X100 mg tablets b.i.d.96 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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Pensacola, Florida, United States
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Safety Harbor, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Wichita, Kansas, United States
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Boston, Massachusetts, United States
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Newark, New Jersey, United States
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Santa Fe, New Mexico, United States
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New York, New York, United States
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The Bronx, New York, United States
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Huntersville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Longview, Texas, United States
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Annandale, Virginia, United States
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Buenos Aires, Argentina
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Córdoba, Argentina
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Neuquén, Argentina
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San Juan Bautista, Argentina
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Curitiba, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Providencia, Chile
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Santiago, Chile
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San José, Costa Rica
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Bordeaux, France
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Lyon, France
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Marseille, France
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Paris, France
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Guadalajara, Mexico
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Mex Ctity, Mexico
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Mexico City, Mexico
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Panama City, Panama
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San Juan, Puerto Rico
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San Juan Pr, Puerto Rico
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Bangkok, Thailand
Unknown Facility
Khon Kaen, Thailand
Related Publications (5)
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.
PMID: 19710593RESULTKakuda 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.
PMID: 20881958DERIVEDClotet 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.
PMID: 20801782DERIVEDVingerhoets 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.
PMID: 20507207DERIVEDMadruga 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.
PMID: 17617270DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 15, 2005
Study Start
November 1, 2005
Primary Completion
February 1, 2007
Study Completion
July 1, 2008
Last Updated
June 20, 2014
Record last verified: 2014-06