TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

Completed · Phase 2

Conditions studied: HIV-1

In brief

The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.

Key facts

Study ID

NCT00665847

Run by

Tibotec Pharmaceuticals, Ireland

People needed

103

Starts

2008-11-01

Expected to finish

2011-08-01

Last updated by the study team

2015-04-23

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infected
• 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

You may not qualify if…

• The Key Exclusion Criteria are: Evidence of resistance to etravirinel Any grade 3 or 4 toxicity (More information available in the protocol)
• Use of disallowed concomitant therapy (specified in the protocol)
• 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)

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — New Orleans, Louisiana, United States
• Study site — St Louis, Missouri, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Syracuse, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Belo Horizonte, Brazil
• Study site — Ribeirão Preto, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — Ottawa, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Lyon, France
• Study site — Nantes, France
• Study site — Paris, France
• Study site — Toulouse Cedex 3 N/A, France
• Study site — Amsterdam-Zuidoost, Netherlands

Full record on ClinicalTrials.gov

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