TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV
Condition: HIV-1 Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to continue to provide Darunavir (DRV) to pediatric
      patients who previously received DRV in any of three pediatric clinical studies sponsored by
      Tibotec Pharmaceuticals and continue to benefit from using it, in countries where DRV is not
      yet commercially available for the pediatric patient, is not reimbursed or cannot be accessed
      through another source (like access program or government program).
    

Detailed description: 
      This study has the aim to continue the provision of DRV and rtv to pediatric patients that
      continue to benefit from treatment with it after participation in any of three ongoing
      pediatric studies sponsored by Tibotec Pharmaceuticals. In addition, information on the
      safety of DRV and rtv in combination with other antiretroviral therapies will be assessed. At
      the baseline visit, inclusion and exclusion criteria will be checked to confirm eligibility.
      Once eligible, patients will continue treatment either on the once daily dose regimen (when
      coming from the TMC114-TiDP29-C230 study) or a twice daily regimen (when coming from the
      TMC114-C212 or TMC114-TiDP29-C228 studies). Assessments and visit frequency will take place
      as per local standard of care but are desirable every 3 months. The interval between two
      visits should not exceed 6 months. Pregnancy testing for girls having had their first menses
      is foreseen. In addition, it is desirable that testing includes efficacy assessments
      (immunology and plasma viral load) and laboratory safety assessments (hematology,
      biochemistry including pancreatic amylase (if available) or lipase and lipid analysis).
      Serious Adverse Events and certain selected Adverse Events will be collected. Treatment will
      be continued until one of the following criteria is met (whichever occurs first): Virologic
      failure, treatment limiting toxicity, loss to follow-up, withdrawal of consent or assent by
      the patient or withdrawal of consent by the caregiver, pregnancy, termination of the trial by
      the sponsor, when Darunavir becomes commercially available, is reimbursed or can be accessed
      through another source (as there are access program or government program) in the region the
      patient is living in. The sponsor advises participating centers to plan the study visits
      every 3 months but frequency will depend on local practice and standard of care. The sponsor
      has also foreseen in the study protocol a guidance on specific safety assessments to be
      performed as well as detailed instructions on how to deal with specific toxicities and
      undesirable effects. However local practice will prevail and the assessments performed may
      vary depending on the region the patient is participating in. Intake of study medication will
      happen once daily or twice daily, depending on what the patient took in the original
      pediatric trial. For the twice daily regimen, the regimen may be adjusted as the patient
      gains weight. The adult dosage regimen of 600/100 mg DRV/rtv may be administered as of 40 kg
      of body weight. Depending on the history of the patient, following dosages may be
      administered: DRV oral suspension (100mg DRV/ml), DRV tablets 75 mg, 150 mg, 600 mg, all for
      twice daily intake. DRV 400 mg for the once daily 800 mg intake (2 tablets per intake).DRV
      intake will be combined with rtv in oral suspension (80 mg rtv/ml), capsule or tablet (both
      100 mg).
    

Intervention name(s): Darunavir; Ritonavir; Ritonavir; Darunavir; Ritonavir; Darunavir; Darunavir; Darunavir; Ritonavir; Darunavir; Ritonavir; Darunavir; Darunavir; Ritonavir; Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg; Liquid formulation, 80 mg/ml, taken in combination with Darunavir; 100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule; Oral suspension 100 mg/ml, 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg; 100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule; 375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg; 450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg; 400 mg tablet, intake of 2 tablets once daily in combination with ritonavir; 100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule; 375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg; Liquid formulation, 80 mg/ml, taken in combination with Darunavir; 450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg; 600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg; 100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule; Ritonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir.
Intervention MeSH terms: Ritonavir; Darunavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC114; TMC114-TiDP29-C232; TMC114-C232; Darunavir; PREZISTA