A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: darunavir; ritonavir; zidovudine; lamivudine; abacavir
Intervention description: 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
Intervention MeSH terms: Ritonavir; Darunavir; Lamivudine; Zidovudine; Abacavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: HIV Infections; TMC114-TiDP29-C230; TMC114-C230; TMC114; HIV-1; Darunavir; Ritonavir; NRTI; Treatment Naive

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a documented HIV-1 infection

          -  Body weight from at least 40 kg at screening

          -  Screening plasma HIV-1 RNA >= 1000 copies/mL

          -  Parents or legal representative and trial patients (where appropriate, depending on
             age and local regulation) willing and able to give consent and assent

          -  General medical condition, in the investigator's opinion, does not interfere with the
             assessments and the completion of the trial

          -  Able to swallow darunavir tablets (400 mg) and ritonavir capsules (100 mg)

        Exclusion Criteria:

          -  Patients with presence of any currently active conditions included in the listing of
             World Health Organisation (WHO) Clinical Stage 4

          -  Any condition (including, but not limited to, alcohol and drug use), which, in the
             opinion of the investigator, could compromise the patient's safety or adherence to the
             trial protocol

          -  Previous or current use of antiretrovirals (ARVs)

          -  Primary or acute HIV infection

          -  Use of any investigational agents within 30 days prior to screening

          -  Use of disallowed concomitant therapy

          -  Pregnant or breast-feeding

          -  Female patient of childbearing potential without use of effective non-hormonal birth
             control methods or not willing to continue practicing these birth control methods for
             at least 30 days after the end of the treatment period

          -  Patients with clinical or laboratory evidence of significantly decreased hepatic
             function or decompensation (ie, liver insufficiency), irrespective of liver enzyme
             levels

          -  Any active clinically significant disease (eg, cardiac dysfunction, pancreatitis,
             acute viral infection) or findings during screening of medical history or physical
             examination that are expected to compromise the patient's safety or outcome in the
             trial