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:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT00069004
Eligibility Criteria:
Inclusion Criteria
For HIV uninfected participants (Group 1)
* HIV-1 negative (perinatally HIV-exposed but uninfected participants are eligible)
For HIV infected participants (Groups 2 and 3)
* Mother-to-child (vertically) transmitted HIV infection
* Confirmed diagnosis of HIV-1 infection by two positive assays from two different samples
* For Group 2, cannot have taken a PI-containing regimen in the 12 months prior to study entry or have ever received a PI for 2 or more weeks
* For Group 3, must currently be taking the same PI-containing regimen taken continuously for at least 12 months prior to study entry
For all participants
* Accessible medical and medications history
* Parent, legal guardian, or participant willing to give informed consent and willing to comply with study requirements
* Females who have begun menstruating must have negative pregnancy test
Exclusion Criteria
* Receipt of certain medications, including growth hormone, megestrol acetate, anabolic agents, anticytokine agents, systemic ketoconazole, systemic glucocorticoids (except if receiving stable physiologic doses), or drugs to treat osteoporosis
* Type II diabetes mellitus and unable to omit medication prior to specimen collection
* Pregnancy within the last 12 months, currently pregnant, or breastfeeding
* History of eating disorder
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
25 Years
Study:
NCT00069004
Study Brief:
Protocol Section:
NCT00069004