The purpose of this Phase II trial is to evaluate the pharmacokinetics (blood levels), 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 HIV 1 infected children aged from 3 years to < 6 years and weighing between 10 kg and < 20 kg . MedDRA version: 16.1 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 100000004862
Conditions
Interventions
Product Name: Darunavir oral suspension (F052)
Pharmaceutical Form: Oral suspension
INN or Proposed INN: DARUNAVIR
CAS Number: 206361-99-1
Current Sponsor code: Darunavir ethanolate
Other descriptive
Sponsors
Tibotec Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 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 1000 copies/mL; Screening genotype resistance test results showing =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with presence of any currently active conditions included in the listing of WHO ( World Health Organisation ) Clinical Stage 4 and patients 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 (Note: DRV should not be used within 14 days following the use of tipranavir); A minimal 14 day washout period is required in which tipranavir must be either interrupted or substituted to an investigator selected PI regimen until the baseline visit; Co-enrollment in other clinical and/or cohort trials without written permission of the Sponsor; Any active clinically significant disease (e.g., 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 trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetic profile of DRV in combination with low-dose ritonavir administered b.i.d. at steady-state in children aged from 3 years to < 6 years and weighing between 10 kg and < 20 kg. ;Primary end point(s): Primary analysis;Timepoint(s) of evaluation of this end point: when all subjects have been treated for 24 weeks or discontinued earlier;Secondary Objective: To evaluate long-term safety, tolerability and efficacy of DRV/rtv administered b.i.d. with other ARV agents over a 48-week treatment period at the recommended dose for HIV-1 infected children aged from 3 years to < 6 years. To evaluate immunology, resistance characteristics, pharmacokinetics, and pharmacokinetic/pharmacodynamic (PK/PD) relationships over 48 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Final analysis;Timepoint(s) of evaluation of this end point: When all subjects have been treated for 48 weeks, or have dropped out earlier (early withdrawal). | — |
Countries
Argentina, Brazil, India, Kenya, South Africa
Contacts
Public ContactJanssen Biologics BV
Janssen-Cilag International NV - Clinical Registry Group
Outcome results
None listed