Pharmacy and Poisons Board
Protocol No: ECCT/17/06/02 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
Study Objectives:

1.0OBJECTIVES

1.1Part 1 Objectives

  • To evaluate the steady-state pharmacokinetics of RPV 25 mg q.d. or adjusted dose of RPV (q.d.) in participants aged ≥6 to <12 years;
  • To evaluate short-term safety, tolerability and antiviral activity/efficacy of RPV in these age groups.

1.2Part 2 Objectives

  • To evaluate safety, tolerability and efficacy of RPV over a 48-week treatment period;
  • To evaluate immunologic changes (as measured by CD4+ cell parameters) over 48 weeks of treatment with RPV;
  • To assess the evolution of viral genotype and phenotype over 48 weeks of treatment with RPV;
  • To evaluate pharmacokinetics and Pharmacokinetic-pharmacodynamic relationships for safety and efficacy of RPV;
  • To evaluate treatment adherence as measured by the Study Adherence Questionnaire for Children and Teenagers;
  • To evaluate the safety, tolerability and efficacy of RPV for up to 240 weeks of treatment.
Laymans Summary:

HIV and AIDs still remain an important public health problem worldwide. It is estimated that 35 million people are living with HIV worldwide, out of which 3 million are children. In Kenya, 1.5 million people are living with HIV of which 200,000 are children less than 15 years of age. Human immunodeficiency virus type 1 (HIV-1) infected patients are routinely treated with a combination of 3 drugs (highly active ARV therapy, HAART), Despite the use of HAART, viral suppression in children is still suboptimal. In Kenya, viral suppression in children is at about 50% as compared to 75% in adults. This study aims to find how effective a new drug called Rilpivirine is in fighting the HIV virus in children equal to or more than 6 years to children less than 12 years. The study will also determine the appropriate dose and safety of Rilpivirine in this age group
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.