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

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

Interventions

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

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

Ritonavir

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

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

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

DRUG

Ritonavir

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

Sponsors & Collaborators

• Janssen Sciences Ireland UC

  lead INDUSTRY

Principal Investigators

• Janssen Sciences Ireland UC Clinical Trial · Janssen Sciences Ireland UC

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-13

Primary Completion

2017-11-23

Completion

2017-11-23

Countries

• Argentina
• Brazil
• France
• India
• South Africa
• Spain
• Ukraine
• United Kingdom

Study Locations