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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen R&D Ireland
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01138605
First received: April 8, 2010
Last updated: August 7, 2014
Last verified: August 2014

April 8, 2010
August 7, 2014
October 2010
December 2014   (final data collection date for primary outcome measure)
Safety and tolerability of DRV/rtv in combination with other ARVs will be summarized in terms of Mortality, all Serious Adverse Events,Adverse events leading to discontinuation and Adverse Events at least possibly related to the DRV treatment [ Time Frame: The outcome will be assessed only when all participants have left the trial. No interim analyis has been foreseen in between and it is estimated that the trial will continue in some of the countries until 2014. ] [ Designated as safety issue: No ]
Safety and tolerabilty of DRV/rtv in combiation with other ARVs will be summarized in terms of Mortality, all Serious Adverse Events,Adverse events leading to discontinuation and Adverse Events at least possibly related to the DRV treatment [ Time Frame: The outcome will be assessed only when all participants have left the trial. No interim analyis has been foreseen in between and it is estimated that the trial will continue in some of the countries until 2014. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01138605 on ClinicalTrials.gov Archive Site
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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
Continued Access to DRV/Rtv in HIV-1 Infected Children and Adolescents (Rollover Patients From C212, C228, C230)

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).

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)

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infections
  • Drug: Darunavir
    600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg
  • Drug: ritonavir
    Liquid formulation, 80 mg/ml, taken in combination with Darunavir
  • Drug: ritonavir
    100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
  • Drug: Darunavir
    Oral suspension 100 mg/ml, 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg
  • Drug: ritonavir
    100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
  • Drug: Darunavir
    375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg
  • Drug: Darunavir
    450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg
  • Drug: Darunavir
    400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
  • Experimental: 005
    Darunavir 400 mg tablet intake of 2 tablets once daily in combination with ritonavir
    Intervention: Drug: Darunavir
  • Experimental: 006
    ritonavir Liquid formulation 80 mg/ml taken in combination with Darunavir
    Interventions:
    • Drug: Darunavir
    • Drug: ritonavir
  • Experimental: 007
    ritonavir 100 mg capsule to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
    Interventions:
    • Drug: Darunavir
    • Drug: ritonavir
  • Experimental: 008
    ritonavir 100 mg tablet to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
    Interventions:
    • Drug: Darunavir
    • Drug: ritonavir
  • Experimental: 001
    Darunavir Oral suspension 100 mg/ml 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg
    Intervention: Drug: Darunavir
  • Experimental: 002
    Darunavir 375 mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight between 20 and 30 kg
    Interventions:
    • Drug: ritonavir
    • Drug: Darunavir
  • Experimental: 003
    Darunavir 450 mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight between 30 and 40 kg
    Interventions:
    • Drug: ritonavir
    • Drug: Darunavir
  • Experimental: 004
    Darunavir 600mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight as of 40 kg
    Interventions:
    • Drug: ritonavir
    • Drug: Darunavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has completed the TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-C230 study and continues to benefit from DRV
  • DRV is not commercially available, not reimbursed or cannot be accessed through another way
  • signed informed consent by parents/caregivers or assent by the patient is available prior to inclusion

Exclusion Criteria:

  • Any condition or active clinically significant disease (such as pancreas problems or cardiac problems) endangering the patient safety while being enrolled in the study
  • Previously demonstrated clinically significant allergy or hypersensitivity to the study medication
  • Pregnancy or breastfeeding female patients
  • Specific criteria will be applicable for girls having had their first menses and for girls and boys having reached the age of sexual activity
Both
3 Years and older
No
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
Argentina,   Brazil,   France,   India,   South Africa,   Spain,   Ukraine,   United Kingdom
 
NCT01138605
CR016768, TMC114-TiDP29-C232
Not Provided
Janssen R&D Ireland
Janssen R&D Ireland
Not Provided
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
Janssen R&D Ireland
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP