Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01138605
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
99 Years
Study:
NCT01138605
Study Brief:
Protocol Section:
NCT01138605