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

Conditions: HIV-1

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.

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 \[\ = 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.

Eligibility criteria:
inclusion criteria: * has documented human immuno deficiency virus (hiv-1) infection * patients who meet the following criteria; a) cohort 1: patients aged greater than or equal to (\>=) 12 to less than (\ = 32 kilogram (kg), b) cohort 2; aged \>= 6 to \ = 17 kg * must have hiv-1 plasma viral load at screening greater than equal to 500 hiv-1 ribonucleic acid (rna) copies/ml * have not received treatment with a therapeutic hiv vaccine or an hiv drug with the exception of a single dose of nevirapine (nvp) (cohort 1 and cohort 2) or up to 6 weeks of zidovudine (azt) use (cohort 2 only) prior to screening to prevent mother-to-child transmission (mtct) * in the judgment of the investigator, it is appropriate to initiate antiretroviral therapy (arv) therapy based on a patient's medical condition and taking into account guidelines for the treatment of hiv-1 infection in children of this age group exclusion criteria: * any previous use of arvs with the exception of single dose nvp (cohort 1 and cohort 2) or up to 6 weeks of azt (cohort 2 only) to prevent mtct * plasma viral load at screening greater than 100,000 hiv-1 rna copies/ml * documented genotypic evidence of non-nucleoside reverse transcriptase inhibitor (nnrti) resistance at screening or from historical data available in the source documents * use of disallowed concomitant therapy from 4 weeks prior to the baseline visit * patient has any currently active acquired immunodeficiency syndrome (aids) defining illness * patient has active tuberculosis and/or is being treated for tuberculosis at screening * personal history of cardiac disease (including congenital heart disease), or symptomatic arrhythmias, with the exception of sinus arrhythmia; personal history of asymptomatic arrhythmias is excluded if the asymptomatic arrhythmia is clinically significant in the opinion of the investigator

Keywords: hiv infection antiretroviral hiv-1 aids children rilpivirine (tmc278) pediatric