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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Antiviral Agents; Etravirine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)