A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents

• Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC 0-12h) - Part 1 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
  
  
• Predose Plasma Concentration (C0) - Part 1 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  The C0 is the predose plasma concentration.
  
  
• Maximum Observed Plasma Concentration (Cmax) - Part 1 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  The Cmax is the maximum observed plasma concentration.
  
  
• Recommended Dose of TMC114 per Body Weight [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  The recommended dose of TMC114 will be determined in participants with a body weight: greater than and equal to 20 Kilogram (kg) to less than 30 kg; greater than and equal to 30 kg to less than 40 kg; and greater than 40 kg.
  
  
• Change From Baseline in Plasma Viral Load at Week 2 - Part 1 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  Plasma viral load levels will be determined using Roche amplicor human immunodeficiency virus (HIV)-1 monitor test (Version 1.5).
  
  
• Change From Baseline in Plasma Viral Load at Week 24- Part 2 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  Plasma viral load levels will be determined using Roche amplicor HIV-1 monitor test (Version 1.5).
  
  
• Number of Participants With Adverse Events [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
  Adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment.
  
  
• Number of Participants With Adverse Events [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  Adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which does not necessarily have a causal relationship with the treatment.
  
  

• Change From Baseline in Plasma Viral Load at Week 48 - Part 2 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  Plasma viral load levels will be determined using Roche amplicor HIV-1 monitor test (Version 1.5).
  
  
• Change from Baseline in Cluster of Differentiation 4 (CD4+) cell count - Part 2 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  The immunologic change will be determined by changes in CD4+ cell count.
  
  
• Number of Participants With Resistance - Part 2 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  Resistance will be determined by viral phenotype and genotype determinations, which will be performed by Virco BVBA, by means of the antivirogram and Virco type HIV-1 respectively. Resistance determinations will only be generated if the viral load is greater than 1000 HIV-1 RNA copies/milliliter.
  
  
• Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC 0-12h) - Part 2 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
  
  
• Predose Plasma Concentration (C0) - Part 2 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  The C0 is the predose plasma concentration.
  
  
• Oral Clearance (CL/F) - Part 2 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  The CL/F is the oral clearance; that is clearance based on oral bioavailability.
  
  

This is an open-label (all people know the identity of the intervention) and randomized (study drug assigned by chance) study to evaluate pharmacokinetics, safety, tolerability, efficacy, antiviral activity, immunology and resistance characteristics of TMC114 with ritonavir in treatment-experienced, HIV-1 infected children and adolescent participants. The study consists of 3 periods: Screening period (maximum 4 weeks); Treatment period (maximum 48 weeks); and Follow-up period (4 weeks). The Treatment period consists of two parts: Part-1 for pediatric dose selection and Part-2 for the recommendation of pediatric or adult dose. Part-1 was further divided into two groups: Group A with adult equivalent dose of TMC114 with ritonavir twice daily and Group B with 20-33 percent higher dose of TMC114 with ritonavir twice daily. The recommended dose will be selected based on short-term safety, tolerability, antiviral activity and pharmacokinetics at Week 2. Once selected, all Part-1 participants who will not be on the selected dose will be switched to the selected dose at their next visit and will continue the study up to 48 weeks in Part-2. Participants with less than or equal to 18 years at Week 48 visit, and continued to benefit from treatment with TMC114 and will be living in a country where TMC114 pediatric use is not yet part of the label, will have the opportunity to roll-over to the extension phase where they will continue to receive TMC114/ritonavir until the participant became 18 years and TMC114 will be available through the local Health Care Systems or until TMC114 is indicated for use in pediatrics. Efficacy will primarily be evaluated by virologic response. Participants' safety will be monitored throughout the study.