A Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of rilpivirine (TMC278) in antiretroviral naïve HIV-1 infected adolescents and children aged ≥6 to <18 years

Principle Instigator
Prof. Walter Jaoko

Objectives of Part 1 are: To evaluate the steady-state pharmacokinetics of RPV 25 mg q.d. or adjusted dose of RPV (q.d.) in subjects aged ³12 to <18 years and ³6 to <12 years;  to evaluate short-term safety, tolerability and antiviral activity/efficacy of RPV in these age groups.

The objectives of Part 2 are:  To evaluate safety, tolerability and efficacy of RPV over a 24-week (Cohort 1 only) and 48-week (Cohort 1 and 2) treatment period to evaluate immunologic changes (as measured by CD4+ cell parameters) over24 weeks (Cohort 1 only) and 48 weeks (Cohort 1 and 2) of treatment with RPV; to assess the evolution of viral genotype and phenotype over 24 weeks (Cohort 1 only) and 48 weeks (Cohort 1 and 2) of treatment with RPV;

to evaluate pharmacokinetics (by means of population pharmacokinetics) and

pharmacokinetic- pharmacodynamic relationships for safety and efficacy of RPV;

to evaluate treatment adherence as measured by the Study Adherence