A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents
Condition: HIV-1; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug
      enters and leaves the blood and tissues over time), safety, tolerability and antiviral
      activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral
      agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and
      adolescents.
    

Detailed description: 
      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.
    

Intervention name(s): TMC114; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): TMC114 will be administered as oral tablets (75 milligram [mg] or 300 mg) twice daily at a dose ranging from 300-600 mg up to 48 weeks.; Ritonavir will be administered as oral capsules (100 mg) or liquid (80 mg/mL) twice daily at a dose ranging from 50 mg (0.625 mL)-100 mg up to 48 weeks.
Other intervention name(s): Darunavir
Intervention MeSH terms: Ritonavir; Darunavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; Darunavir; Ritonavir; TMC114