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

NCT01138605 | Completed Phase 2

• 3 other identifiers: CR016768TMC114-TiDP29-C2322009-017013-29
• Study Type: interventional
• Target: 46
• Locations: 8 countries
• Sites: 13

Brief 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).

Conditions

HIV-1 Infections

Keywords

TMC114; TMC114-TiDP29-C232; TMC114-C232; Darunavir; PREZISTA

Outcome Measures

Primary Outcomes (1)

• 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

  Variable, up to 7 years

Study Arms (9)

005

EXPERIMENTAL

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

Drug: Darunavir

006

EXPERIMENTAL

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

Drug: Darunavir; Drug: Ritonavir

007

EXPERIMENTAL

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

Drug: Darunavir; Drug: Ritonavir

008

EXPERIMENTAL

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

Drug: Darunavir; Drug: Ritonavir

001

EXPERIMENTAL

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

002

EXPERIMENTAL

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; Drug: Darunavir

003

EXPERIMENTAL

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; Drug: Darunavir

004

EXPERIMENTAL

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

Drug: Ritonavir; Drug: Darunavir

009

EXPERIMENTAL

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

Drug: Ritonavir

Interventions

Darunavir DRUG

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

008

Ritonavir DRUG

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

002

Eligibility Criteria

• Age: 3 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead

Study Sites (13)

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Ciudad Autonoma Buenos Aires, Argentina

Location

Unknown Facility

Ribeirão Preto, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Chennai, India

Location

Unknown Facility

Durban Kwazulu Natal, South Africa

Location

Unknown Facility

Gauteng, South Africa

Location

Unknown Facility

Johannesburg, South Africa

Location

Unknown Facility

Esplugues de Llobregat, Spain

Location

Unknown Facility

Kyiv, Ukraine

Location

Unknown Facility

Birmingham, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33367975 DERIVED

Related Links

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

MeSH Terms

Interventions

Darunavir; Ritonavir

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Study Officials

• Janssen Sciences Ireland UC Clinical Trial

  Janssen Sciences Ireland UC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: June 7, 2010
• Study Start: October 13, 2010
• Primary Completion: November 23, 2017
• Study Completion: November 23, 2017
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

IN (1); GB (1); UA (1); FR (1); ES (1); AR (2); BR (3); ZA (3)