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:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT01225406
Eligibility Criteria:
Inclusion Criteria:
Children (\< 18 years old) with HIV infection may enroll if one of the following criteria is met:
1. Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA \> 1000 copies/ml prior to switching to third line ARV therapy
2. Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir
Exclusion Criteria:
1. Have hepatic impairment with ALT ≥ 5 upper limit of normal
2. Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01225406
Study Brief:
Protocol Section:
NCT01225406