A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth

Completed

Conditions studied: HIV Infections, HIV-Associated Lipodystrophy Syndrome, HIV Lipodystrophy Syndrome, Lipodystrophy, Dyslipidemia, Osteoporosis, Osteopenia

In brief

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).

Key facts

Study ID

NCT00069004

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

450

Starts

2003-10-01

Expected to finish

2005-08-01

Last updated by the study team

2014-01-07

Who can join

Age: 7 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham, Alabama, United States
• Usc La Nichd Crs — Alhambra, California, United States
• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• UCSD Mother-Child-Adolescent Program CRS — San Diego, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
• Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy — Gainesville, Florida, United States
• USF - Tampa NICHD CRS — Tampa, Florida, United States
• Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Augusta, Georgia, United States
• Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases — New Brunswick, New Jersey, United States
• Rutgers - New Jersey Medical School CRS — Newark, New Jersey, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States
• Nyu Ny Nichd Crs — New York, New York, United States
• Metropolitan Hosp. Ctr. — New York, New York, United States
• Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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