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.
NCT ID: NCT00254046
Last Updated: 2014-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
616 participants
INTERVENTIONAL
2005-11-30
2008-07-31
Brief Summary
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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.
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TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial
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TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients
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TMC125-C223: TMC125 in HIV-1 Infected Subjects
NCT00081978
TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use
NCT00225303
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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002
Placebo 2 tablets b.i.d.96 weeks
Placebo
2 tablets b.i.d.96 weeks
001
TMC125 2 X100 mg tablets b.i.d.96 weeks
TMC125
2 X100 mg tablets b.i.d.96 weeks
Interventions
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TMC125
2 X100 mg tablets b.i.d.96 weeks
Placebo
2 tablets b.i.d.96 weeks
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
* Use of disallowed concurrent therapy
* Any active clinically significant disease
18 Years
ALL
No
Sponsors
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Tibotec Pharmaceuticals, Ireland
INDUSTRY
Responsible Party
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Principal Investigators
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Tibotec Pharmaceuticals Clinical Trial
Role: STUDY_DIRECTOR
Tibotec Pharmaceutical Limited
Locations
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Little Rock, Arkansas, United States
Beverly Hills, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Pensacola, Florida, United States
Safety Harbor, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Wichita, Kansas, United States
Boston, Massachusetts, United States
Newark, New Jersey, United States
Santa Fe, New Mexico, United States
New York, New York, United States
The Bronx, New York, United States
Huntersville, North Carolina, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
Annandale, Virginia, United States
Buenos Aires, , Argentina
Córdoba, , Argentina
Neuquén, , Argentina
San Juan Bautista, , Argentina
Curitiba, , Brazil
Rio de Janeiro, , Brazil
Salvador, , Brazil
São Paulo, , Brazil
Providencia, , Chile
Santiago, , Chile
San José, , Costa Rica
Bordeaux, , France
Lyon, , France
Marseille, , France
Paris, , France
Guadalajara, , Mexico
Mex Ctity, , Mexico
Mexico City, , Mexico
Panama City, , Panama
San Juan, , Puerto Rico
San Juan Pr, , Puerto Rico
Bangkok, , Thailand
Khon Kaen, , Thailand
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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TMC125-C206
Identifier Type: -
Identifier Source: secondary_id
CR002752
Identifier Type: -
Identifier Source: org_study_id
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