A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
Condition: HIV-1 Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate pharmacokinetics (what body does to medication),
      safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir
      (DRV/rtv) administered once daily, in combination with an investigator-selected background
      regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse
      transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected
      adolescents aged from 12 to <18 years and weighing at least 40 kg.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-arm, Phase
      II study to evaluate the pharmacokinetics, safety, tolerability, and efficacy of
      darunavir/ritonavir (DRV/rtv) administered once daily, in combination an
      investigator-selected background regimen (2 NRTIs), in treatment-naive HIV-1 infected
      adolescents over 48 weeks. A total of 12 patients will be enrolled in this study. Patients
      will be considered treatment-naive if they have never received treatment with an ARV
      medication, including both investigational as well as commercially available ARVs indicated
      for the treatment of HIV-infection and ARVs for the treatment of hepatitis B infection with
      anti-HIV activity. The investigator-selected background regimen will consist of 2 NRTIs,
      either zidovudine/lamivudine or abacavir/lamivudine, whichever is approved and marketed or
      considered local standard of care for adolescents aged from 12 to <18 years in a particular
      country. The study will consist of a 4-week screening period, a 48-week treatment period, and
      a 4-week follow-up period. Safety, efficacy, resistance (reduction in effectiveness of a
      medication), pharmacokinetic analyses, and pharmacodynamic (what medication does to body)
      analyses will be performed at Week 24 (primary analysis) and Week 48 (final analysis).
      Patients who will complete the 48 weeks of treatment with DRV/rtv and who will continue to
      benefit from this treatment, will have the opportunity to continue this treatment until they
      no longer benefit from the medication, until DRV is commercially available or can be accessed
      from another source (eg, access program, government program) or until the development program
      is discontinued.
    

Intervention name(s): darunavir; ritonavir; zidovudine; lamivudine; abacavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=400, formulation=tablet, route=oral. 2 tablets of darunavir administered once daily for 48 weeks; Type=exact number, unit=mg, number=100, formulation=capsule, route=oral. 1 capsule of ritonavir administered once daily for 48 weeks; NRTI (zidovudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country; NRTI (lamivudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country; NRTI (abacavir) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country
Other intervention name(s): DRV; rtv
Intervention MeSH terms: Ritonavir; Darunavir; Lamivudine; Zidovudine; Abacavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Infections; TMC114-TiDP29-C230; TMC114-C230; TMC114; HIV-1; Darunavir; Ritonavir; NRTI; Treatment Naive