TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
NCT ID: NCT00665847
Last Updated: 2015-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2008-11-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Etravirine (TMC125)
Etravirine (TMC125)
Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks.
Optimized background regimen (OBR)
An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir \[LPV\], darunavir \[DRV\], atazanavir \[ATV\] or saquinavir \[SQV\]) in combination with nucleos(t)ide reverse transcriptase inhibitor(s) (N\[t\]RTIs) to be dosed according to the drugs individual package inserts for 48 weeks.
Interventions
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Etravirine (TMC125)
Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks.
Optimized background regimen (OBR)
An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir \[LPV\], darunavir \[DRV\], atazanavir \[ATV\] or saquinavir \[SQV\]) in combination with nucleos(t)ide reverse transcriptase inhibitor(s) (N\[t\]RTIs) to be dosed according to the drugs individual package inserts for 48 weeks.
Eligibility Criteria
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Inclusion Criteria
* Body weight according to age within the 10-90th percentile of CDC growth chart
* On steady antiretroviral therapy regimen for at least 8 weeks at screening and willing to remain on that regimen until baseline
* HIV viral load of 1,000 copies/ml or greater at study entry
* Parent or legal guardian willing to provide informed consent, if necessary
Exclusion Criteria
* Currently active AIDS defining illness (category C)
* Active hepatitis A, B or C virus infection
* Any clinically significant diseases or findings that, in the opinion of the investigator, would interfere with the study
* Receipt of any ARV or non-ARV investigational medication or investigational vaccine within 30 days prior to screening
* History of clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125)
6 Years
17 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, Ireland Clinical Trial
Role: STUDY_DIRECTOR
Tibotec Pharmaceuticals, Ireland
Locations
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Mobile, Alabama, United States
Los Angeles, California, United States
Washington D.C., District of Columbia, United States
New Orleans, Louisiana, United States
St Louis, Missouri, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Buenos Aires, , Argentina
Belo Horizonte, , Brazil
Ribeirão Preto, , Brazil
Rio de Janeiro, , Brazil
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Lyon, , France
Nantes, , France
Paris, , France
Toulouse Cedex 3 N/A, , France
Amsterdam-Zuidoost, , Netherlands
Almada, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Rio Piedras, , Puerto Rico
San Juan, , Puerto Rico
Bucharest, , Romania
Constanța, , Romania
Dundee, , South Africa
Durban, , South Africa
Port Elizabeth, , South Africa
Barcelona, , Spain
Esplugues de Llobregat, , Spain
Madrid, , Spain
Seville, , Spain
Bangkok, , Thailand
Khon Kaen, , Thailand
Birmingham, , United Kingdom
Countries
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References
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Tambuyzer L, Thys K, Hoogstoel A, Nijs S, Tomaka F, Opsomer M, De Meyer S, Vingerhoets J. Assessment of etravirine resistance in HIV-1-infected paediatric patients using population and deep sequencing: final results of the PIANO study. Antivir Ther. 2016;21(4):317-27. doi: 10.3851/IMP3011. Epub 2015 Nov 13.
Other Identifiers
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TMC125-TiDP35-C213
Identifier Type: OTHER
Identifier Source: secondary_id
2007-007086-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR002746
Identifier Type: -
Identifier Source: org_study_id
NCT00750542
Identifier Type: -
Identifier Source: nct_alias
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