Status:
COMPLETED
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV-1
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
The study design is a single arm treatment (all patients assigned to receive etravirine), open label (patients will know the identity of the treatments they are receiving) safety and antiviral activit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00665847
Start Date
November 1 2008
End Date
August 1 2011
Last Update
April 23 2015
Active Locations (42)
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1
Mobile, Alabama, United States
2
Los Angeles, California, United States
3
Washington D.C., District of Columbia, United States
4
New Orleans, Louisiana, United States