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
  Purpose

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).


Condition Intervention Phase
HIV-1 Infections
Drug: Darunavir
Drug: ritonavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continued Access to DRV/Rtv in HIV-1 Infected Children and Adolescents (Rollover Patients From C212, C228, C230)

Resource links provided by NLM:


Further study details as provided by Janssen R&D Ireland:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 46
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 005
Darunavir 400 mg tablet intake of 2 tablets once daily in combination with ritonavir
Drug: Darunavir
Oral suspension 100 mg/ml, 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg
Experimental: 006
ritonavir Liquid formulation 80 mg/ml taken in combination with Darunavir
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: ritonavir
Liquid formulation, 80 mg/ml, taken in combination with Darunavir
Experimental: 007
ritonavir 100 mg capsule to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
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: ritonavir
100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
Experimental: 008
ritonavir 100 mg tablet to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
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
100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
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
Drug: Darunavir
400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
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
Drug: ritonavir
Liquid formulation, 80 mg/ml, taken in combination with Darunavir
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
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
Drug: ritonavir
100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
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
Experimental: 004
Darunavir 600mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight as of 40 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
600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg

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)

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138605

Contacts
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

Locations
Argentina
Recruiting
Buenos Aires, Argentina
Active, not recruiting
Buenos Aires, Argentina
Withdrawn
Buenos Aires, Argentina
Recruiting
C 1249 Abp - Buenos Aires, Argentina
Brazil
Withdrawn
Belo Horizonte, Brazil
Recruiting
Ribeirao Preto, Brazil
Active, not recruiting
Rio De Janeiro, Brazil
Recruiting
Rio De Janeiro, Brazil
Active, not recruiting
Sao Paulo, Brazil
France
Active, not recruiting
Paris, France
India
Active, not recruiting
Chennai, India
South Africa
Withdrawn
Cape Town Cape, South Africa
Active, not recruiting
Durban Kwazulu Natal, South Africa
Active, not recruiting
Johannesburg, South Africa
Spain
Active, not recruiting
Esplugues De Llobregat, Spain
Ukraine
Withdrawn
Kiev, Ukraine
Active, not recruiting
Kyiv, Ukraine
United Kingdom
Completed
Birmingham, United Kingdom
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01138605     History of Changes
Other Study ID Numbers: CR016768, TMC114-TiDP29-C232
Study First Received: April 8, 2010
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Janssen R&D Ireland:
TMC114
TMC114-TiDP29-C232
TMC114-C232
Darunavir
PREZISTA

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014