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

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.

Inclusion Criteria:

- Has diagnosed with 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 (<) 18 years, weight is >= 32 kilogram (kg), b) Cohort
2; Aged >= 6 to < 12 years, weight is >= 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

- In the judgment of the investigator, it is appropriate to initiate anti retroviral
therapy (ARV) therapy based on the patients 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 mother-to-child transmission (MTCT)

- Plasma viral load at screening greater than 100,000 HIV-1 ribonucleic acid (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