A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth (NCT00069004) | Clinical Trial Compass
CompletedNot Applicable
A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
United States450 participantsStarted 2003-10
Plain-language summary
The purpose of this study is to assess the prevalence of metabolic and physical abnormalities in HIV infected (via mother-to-child transmission) and uninfected children and youth. Metabolism, body composition, bone density, and other factors will be assessed in relationship to participants' exposure to highly active antiretroviral therapy (HAART).
Who can participate
Age range7 Years ā 25 Years
SexALL
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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
Trial details
NCT IDNCT00069004
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)