A phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of TMC278 in antiretroviral naive HIV-1 infected adolescents aged 12 to < 18 years

Project no.: HIV-NAT 099/TMC278-TiDP38-C213 (PAINT) (NCT00799864)

This is a Phase II, open-label (all people involved know the identity of the assigned drug) and single arm study. The purpose of this study is to evaluate the pharmacokinetics, safety and effectiveness of TMC278 25 mg once daily in combination with an investigator-selected background regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs)