Protocol No: | ECCT/16/10/02 | Date of Protocol: | 18-12-2015 |
Study Title: |
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
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Study Objectives: | |
Laymans Summary: | |
Abstract of Study: | This is a Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability and efficacy of rilpivirine (RPV, previously known as TMC278) 25 mg once daily (q.d.) or an adjusted dose of RPV (q.d.) in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) (zidovudine [AZT], abacavir [ABC], or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC], whichever is approved and marketed or considered local standard of care) in antiretroviral (ARV) treatment-naïve adolescents and children aged ≥ 6 to <18 years. The trial will consist of a screening period of maximum 8 weeks, an initial treatment period of 48 weeks, and a post Week 48 treatment extension period of 4 years. Subjects who withdraw from the trial on or before the Week 48 visit or subjects with ongoing (serious) adverse events ([S]AEs) at the last on-treatment visit in the extension, will be seen for a follow-up visit 4 weeks later. Recruitment and analyses of the initial 48-week treatment period will be structured into 2 age cohorts: Cohort 1, adolescents ≥12 to <18 years of age; Cohort 2, children ≥6 to <12 years of age. |