Status:
COMPLETED
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
Lead Sponsor:
Janssen Sciences Ireland UC
Conditions:
HIV-1 Infections
Eligibility:
All Genders
3-99 years
Phase:
PHASE2
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 Pharmace...
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 spon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01138605
Start Date
October 13 2010
End Date
November 23 2017
Last Update
May 1 2019
Active Locations (13)
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1
Buenos Aires, Argentina
2
Ciudad Autonoma Buenos Aires, Argentina
3
Ribeirão Preto, Brazil
4
Rio de Janeiro, Brazil