A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents.
- Conditions
- AIDSHIV-infection10047438
- Registration Number
- NL-OMON31931
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 2
Children and adolescents aged 6 years to 17 years inclusive
Both male and female patients
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 500 copies/ml or greater at study entry
Parent or legal guardian willing to provide informed consent, if necessary
Evidence of resistance to etravirine
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method