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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

NCT ID: NCT01138605

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-13

Study Completion Date

2017-11-23

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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HIV-1 Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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005

Darunavir 400 mg tablet intake of 2 tablets once daily in combination with ritonavir

Group Type EXPERIMENTAL

Darunavir

Intervention Type DRUG

Oral suspension 100 mg/ml, 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg

006

Ritonavir Liquid formulation 80 mg/ml taken in combination with Darunavir

Group Type EXPERIMENTAL

Darunavir

Intervention Type DRUG

375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg

Ritonavir

Intervention Type DRUG

Liquid formulation, 80 mg/ml, taken in combination with Darunavir

007

Ritonavir 100 mg capsule to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Group Type EXPERIMENTAL

Darunavir

Intervention Type DRUG

450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg

Ritonavir

Intervention Type DRUG

100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

008

Ritonavir 100 mg tablet to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Group Type EXPERIMENTAL

Darunavir

Intervention Type DRUG

600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg

Ritonavir

Intervention Type DRUG

100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

001

Darunavir Oral suspension 100 mg/ml 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg

Group Type EXPERIMENTAL

Darunavir

Intervention Type DRUG

400 mg tablet, intake of 2 tablets once daily in combination with ritonavir

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

Group Type EXPERIMENTAL

Ritonavir

Intervention Type DRUG

Liquid formulation, 80 mg/ml, taken in combination with Darunavir

Darunavir

Intervention Type DRUG

375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg

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

Group Type EXPERIMENTAL

Ritonavir

Intervention Type DRUG

100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Darunavir

Intervention Type DRUG

450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg

004

Darunavir 600mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight as of 40 kg

Group Type EXPERIMENTAL

Ritonavir

Intervention Type DRUG

100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Darunavir

Intervention Type DRUG

600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg

009

Ritonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir.

Group Type EXPERIMENTAL

Ritonavir

Intervention Type DRUG

Ritonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir.

Interventions

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Darunavir

600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg

Intervention Type DRUG

Ritonavir

Liquid formulation, 80 mg/ml, taken in combination with Darunavir

Intervention Type DRUG

Ritonavir

100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Intervention Type DRUG

Darunavir

Oral suspension 100 mg/ml, 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg

Intervention Type DRUG

Ritonavir

100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Darunavir

400 mg tablet, intake of 2 tablets once daily in combination with ritonavir

Intervention Type DRUG

Ritonavir

100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Intervention Type 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

Intervention Type DRUG

Ritonavir

Liquid formulation, 80 mg/ml, taken in combination with Darunavir

Intervention Type 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

Intervention Type DRUG

Darunavir

600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg

Intervention Type DRUG

Ritonavir

100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Intervention Type DRUG

Ritonavir

Ritonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Sciences Ireland UC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Sciences Ireland UC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Sciences Ireland UC

Locations

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Buenos Aires, , Argentina

Site Status

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Ribeirão Preto, , Brazil

Site Status

Rio de Janeiro, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Paris, , France

Site Status

Chennai, , India

Site Status

Durban Kwazulu Natal, , South Africa

Site Status

Gauteng, , South Africa

Site Status

Johannesburg, , South Africa

Site Status

Esplugues de Llobregat, , Spain

Site Status

Kyiv, , Ukraine

Site Status

Birmingham, , United Kingdom

Site Status

Countries

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Argentina Brazil France India South Africa Spain Ukraine United Kingdom

References

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Violari A, Masenya M, Blanche S, Vanveggel S, Hufkens V, Chetty P, Opsomer M. The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to < 18 Years. Drug Saf. 2021 Apr;44(4):439-446. doi: 10.1007/s40264-020-01032-0. Epub 2020 Dec 24.

Reference Type DERIVED
PMID: 33367975 (View on PubMed)

Related Links

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https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-017013-29/results

Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and above

Other Identifiers

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TMC114-TiDP29-C232

Identifier Type: OTHER

Identifier Source: secondary_id

2009-017013-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016768

Identifier Type: -

Identifier Source: org_study_id

NCT02923713

Identifier Type: -

Identifier Source: nct_alias

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