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

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

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.

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 activity of Etravirine (TMC125) in treatment-experienced, HIV infected children and adolescents 6 to 17 years of age. Etravirine is a new drug belonging to the NNRTI (a non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the human immunodeficiency virus (HIV). This drug has been tested for safety and effectiveness in adults, however, there is no data on the drug's long-term safety and antiviral activity in children and adolescents. This study will last for a maximum of 48 weeks. A total of 100 ptients will receive etravirine tablets based on body weight and an investigator selected optimized background regimen (OBR) of at least 2 antiretrovirals (ARVs), consisting of a boosted protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor(s) (NRTI[s]). Use of enfuvirtide is optional. Safety will be monitored throughout the study.

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)