A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
Condition: Human Immunodeficiency Virus 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Darunavir; Ritonavir
Intervention description: Darunavir oral suspension (100 mg/mL) will be administered as 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg before dose adjustment. Darunavir oral suspension will be administered 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg darunavir tablets twice daily if weight more than or equal to 15 kg after dose adjustment.; Ritonavir oral solution (80 mg/mL) will be administered as 3 mg per kg body weight twice daily before dose adjustment and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg.
Intervention MeSH terms: Ritonavir; Darunavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 3 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Human immunodeficiency virus 1; HIV-1; Darunavir; Ritonavir; Norvir

Summary:

      The purpose of this study is to evaluate the pharmacokinetics (what the body does to the
      medication), safety and antiviral activity to support dose recommendations by body weight of
      darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs
      (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a documented HIV 1 infection (by any of the local standard
             diagnostic methods, such as HIV PCR-DNA, ELISA or western blot (WB) test for HIV
             antibodies, etc.)

          -  Body weight from 10 kg to less than 20 kg at screening

          -  Participants currently on stable ART (anti retroviral therapy) for at least 12 weeks,
             who need to change their ARV regimen because it is currently failing, with a viral
             load of greater than 1000 copies/mL

          -  Screening genotype resistance test results showing less than 3 DRV
             resistance-associated mutations

          -  Parents or legal representative willing and able to give consent

        Exclusion Criteria:

          -  Participants with presence of any currently active conditions included in the listing
             of WHO ( World Health Organisation) Clinical Stage 4 and participants with presence of
             a non-HIV encephalopathy

          -  Administration of any ARV (antiretroviral) or non-ARV investigational medication or
             investigational vaccine within 30 days prior to screening, except for those
             medications where dose recommendations for children are available

          -  Life expectancy less than 6 months, according to the judgment of the investigator

          -  Co-enrollment in other clinical and/or cohort trials without written permission of the
             Sponsor

          -  Participants with any active clinically significant disease (eg, tuberculosis [TB],
             cardiac dysfunction, pancreatitis, acute viral infections) or findings during
             screening of medical history or physical examination that, in the investigator's
             opinion, would compromise the subject's safety or outcome of the study