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

Primary Outcome Measures:

• Pharmacokinetics of Rilpivirine (TMC278) as measured by maximum plasma concentration (Cmax) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  
• Pharmacokinetics of Rilpivirine as measured by area under the plasma concentration curve (AUC24) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  AUC24 is defined area under the plasma concentration time curve from 0 to 24 hours post dosing of rilpivirine.
  
  
• Pharmacokinetics of Rilpivirine as measured by time to reach the maximum plasma concentration (tmax) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  

Secondary Outcome Measures:

• Number of Patients with Adverse Events [ Time Frame: Up to 244 weeks (including 4 week follow up visit) ] [ Designated as safety issue: Yes ]
  Safety measures include adverse events, vital signs, physical examination, hematology, biochemistry and electrocardiogram
  
  
• Percentage of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) level Less Than (<) 50 Copies/mL Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  Time to loss of virologic response algorithm (TLOVR) requires sustained HIV-1 RNA < 50 copies/mL; confirmed HIV-1 RNA more than or equal to (>=) 50 copies/mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation.
  
  
• Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL by FDA Snapshot Approach [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  FDA Snapshot Approach is based on the last observed viral load data within the Week 48 window: virologic response is defined as HIV-1 RNA <50 copies/mL (observed case); missing HIV-1 RNA is considered as non-response.
  
  
• Evolution of viral genotype and phenotype [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  This endpoint is measured at week 48 of treatment with rilpivirine.
  
  
• Treatment adherence as measured by the Study Adherence Questionnaire [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  This endpoint is measured by Study Adherence Questionnaire for children and teenagers. The adherence questionnaire should be completed by by the patient. Ths questionnaire includes questions about the medicine, it's color and dosage.
  
  
• Change in Cluster of Differentiation (CD4+) cells [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  Change in the CD4+ cells will evaluate immunologic changes at week 48 of treatment with rilpivirine.
  
  
• Assessment of Pharmacokinetic-Pharmacodynamic Relationships [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  This endpoint evaluates pharmacokinetic-pharmacodynamic relationships for safety and efficacy of rilpivirine.
  
  

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 taking 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) 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 20 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.