A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
Condition: HIV-1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity
      of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily 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] in
      antiretroviral (ARV) treatment-naïve adolescents and children aged greater than or equal to
      (>=) 6 to less than (<) 18 years.
    

Detailed description: 
      This is a Phase II, open-label (all people involved know the identity of the assigned drug)
      and single arm study. The study will consist of a screening period of maximum 8 weeks, an
      initial treatment period of 48 weeks, a post week 48 treatment extension period of 4 years
      (Cohort 1 only), and a 4 week follow-up (cohort 2 only) period. Participants who withdraw
      from the trial on or before the Week 48 visit or subjects with ongoing (serious) adverse
      events ([S]AEs), laboratory abnormalities, or viral load increase at the last on-treatment
      visit in the extension, will be seen for a follow-up visit 4 weeks later. The initial 48-week
      treatment period will be structured into 2 age Cohorts; Cohort 1 (Aged greater than or equal
      to [>=] 12 to less than [<] 18 years) and Cohort 2 (Children Aged >= 6 to < 12 years). The
      trial is designed to evaluate the steady-state pharmacokinetic (PK) profile (based on
      intensive PK analysis) and the short-term safety and antiviral activity of rilpivirine (RPV).
      Participants will receive RPV 25 milligram (mg), or weight-adjusted dose orally once daily
      for 240 weeks when administered in combination with 2 nucleoside/nucleotide reverse
      transcriptase inhibitors (NRTIs). The trial will also evaluate long-term (48 weeks and 240
      weeks [Cohort 1]) safety, efficacy, and pharmacokinetics of rilpivirine in combination with
      the background regimen of 2 NRTIs. Patients safety will be monitored throughout the study and
      during the follow up visits.
    

Intervention name(s): Rilpivirine; Zidovudine; Abacavir; Tenofovir disoproxil fumarate; Lamivudine; Emtricitabine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Patients will receive rilpivirine (RPV) tablet 25 milligram dose or an adjusted dose orally once daily in Cohort 1 (adolescents aged >=12 to <18 years) up to 240 weeks. Patients will receive RPV weight-adjusted dose orally once daily in Cohort 2 (children aged >=6 to <12 years) or 25 mg once daily for up to 48 weeks.; Type=exact, form= appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1).; Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1).; Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for 240 weeks (Cohort 1).; Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1).; Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients may receive this selected NRTI together with another NRTI once daily for up to 48 weeks (Cohort 2) and 240 weeks (Cohort 1).
Intervention MeSH terms: Tenofovir; Lamivudine; Emtricitabine; Zidovudine; Abacavir; Rilpivirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Infection; Antiretroviral; HIV-1; AIDS; Children; Rilpivirine (TMC278); Pediatric