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

• Status: Completed
• Trial end date: 2017-11-23
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Sciences Ireland UC
• Treatments: Darunavir; Pharmaceutical Solutions; Polystyrene sulfonic acid; Ritonavir

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