Last updated on December 2019

A Study to Evaluate the Pharmacokinetics Safety Tolerability and Antiviral Efficacy of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years

Brief description of study

The purpose of this study is to evaluate the pharmacokinetics, safety and effectiveness of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine [AZT]/lamivudine [3TC] or abacavir [ABC]/3TC) in antiretroviral (ARV) treatment.

Detailed Study 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, and a 4 week follow-up period. A follow-up period will take place regardless of the presence of serious adverse events (SAEs) if patients withdraw early (ie, before Week 48) or if patients do not participate in the extension after Week 48; after Week 48, a 4-week follow-up visit is only required in case of ongoing (S)AEs at the final on treatment visit. 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) and each Cohort will have 2 parts. The first part of the trial (Part 1) is designed to evaluate the steady-state pharmacokinetic (PK) profile and the short-term safety and antiviral activity of rilpivirine 25 mg or adjusted dose once daily when administered in combination with 2 NRTIs. At Week 2/4, intensive PK will be done and an analysis together with short-term safety and antiviral activity will be reviewed by a data monitoring committee (DMC). For adolescents (Cohort 1) if the mean steady-state exposure in this first group of patients is comparable to that of the adult population (ie, is within 80-125 percentage of the mean exposure of the 25 mg once daily dose group in study, TMC278-C204), and the Week 2/4 safety and antiviral activity results have been reviewed and deemed satisfactory by the DMC, the second part of the trial will start. The second part of the trial will evaluate long-term (48 weeks and 240 weeks) safety, efficacy, and pharmacokinetics of rilpivirine in combination with the background regimen of 2 NRTIs with a primary analysis time point at 24 weeks. For patients aged greater than or equal to (>=) 6 to less than (<) 12 years (Cohort 2), after being treated for at least 4 weeks and the Week 2 intensive PK and Week 4 safety and antiviral activity have been reviewed and results are satisfactory, recruitment in Part 1 will resume and additional subjects will be enrolled to have at least 10 subjects in Part 1. Once an appropriate RPV dose has been selected, Part 1 of Cohort 2 will be considered complete and Part 2 will start. All patients from Part 1 will roll over in Part 2 and additional patients will be recruited in Part 2 to have at least 25 subjects (including those from Part 1) overall. In both cohorts of the trial, the ART will consist of rilpivirine 25 mg or adjusted dose once daily and an investigator-selected background regimen containing 2 NRTIs. Patients safety will be monitored throughout the study and during the follow up visits.

Clinical Study Identifier: NCT00799864

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