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).

Condition
HIV Infections HIV-Associated Lipodystrophy Syndrome HIV Lipodystrophy Syndrome Lipodystrophy Dyslipidemia Osteoporosis Osteopenia

Further Study Details: 

Expected Total Enrollment:  450

Despite advances in HIV care associated with HAART, many patients on HAART regimens develop physical and metabolic problems, including changes in body fat distribution (lipodystrophy), osteopenia and osteoporosis, dyslipidemia, and hyperlactatemia. Early studies suggest that protease inhibitors (PIs) were directly responsible for HIV Lipodystrophy Syndrome (HLS) and skeletal complications in HAART-treated patients. This study will compare HIV infected, HAART-treated children and youth and their uninfected counterparts to make connections between HAART, HLS, and skeletal and metabolic problems. The study is the first to address the prevalence and risk assessment of these complications in children, and will be useful in predicting long-term prognosis in HIV patients who use or have used HAART.

There will be three groups in the study. Group 1 participants will be uninfected volunteers who will receive no protocol-specific treatment or other intervention. Vertically infected HIV patients in Groups 2 and 3 will continue their current HAART either on a non-PI-containing regimen (Group 2) or a PI-containing regimen (Group 3). Screening evaluations will be conducted within 30 days prior to study entry. Study evaluations may be completed at study entry or over the course of up to 3 study visits. All participants will undergo whole body and regional DEXA scans (to assess bone density), measurements to determine sexual maturity, and blood work.

Ages Eligible for Study:  7 Years   -   25 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Alabama
      University of Alabama at Birmingham (Pediatric), Birmingham,  Alabama,  35233,  United States; Not yet recruiting
California
      Children's Hospital, Oakland (Pediatric), Oakland,  California,  94609-1809,  United States; Not yet recruiting
      UCSF, Moffitt Hospital (Pediatric), San Francisco,  California,  94143-0105,  United States; Recruiting
      Los Angeles County Medical Center/USC, Los Angeles,  California,  90033,  United States; Recruiting
      Childrens Hospital of Orange County, Orange,  California,  92868,  United States; Recruiting
      UCSD Mother, Child & Adolescent HIV Program, San Diego,  California,  92103,  United States; Recruiting
      Harbor-UCLA Medical Center, Torrance,  California,  90509,  United States; Recruiting
      UCLA Medical Center (Pediatric), Los Angeles,  California,  90095-1752,  United States; Recruiting
Colorado
      Childrens Hospital (U. Colorado Denver), Denver,  Colorado,  80218-1088,  United States; Recruiting
Connecticut
      Yale University School of Medicine, New Haven,  Connecticut,  06504,  United States; Recruiting
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  United States; Recruiting
      Howard University Hospital, Washington,  District of Columbia,  20060,  United States; Recruiting
Florida
      North Broward Hospital District, Fort Lauderdale,  Florida,  33316,  United States; Recruiting
      University of Florida, Gainesville, Gainesville,  Florida,  32610-0296,  United States; Recruiting
Georgia
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States; Recruiting
Illinois
      Chicago Childrens Memorial Hospital (pediatric), Chicago,  Illinois,  60614,  United States; Recruiting
      Womens & Childrens HIV Program, Chicago,  Illinois,  60608-1797,  United States; Recruiting
      University of Illinois, Chicago,  Illinois,  60612-7234,  United States; Recruiting
Louisiana
      Tulane Univ., Charity Hospital of New Orleans, New Orleans,  Louisiana,  70112-2699,  United States; Recruiting
Maryland
      Johns Hopkins University (Pediatric), Baltimore,  Maryland,  United States; Recruiting
      University of Maryland (Pediatric), Baltimore,  Maryland,  21201,  United States; Recruiting
Massachusetts
      Children's Hospital of Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
      Boston Medical Center (Pediatric), Boston,  Massachusetts,  02118,  United States; Recruiting
Michigan
      Childrens Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Not yet recruiting
New Jersey
      University of Med. & Dentistry of NJ/Univ. Hospital, Newark,  New Jersey,  07101-1709,  United States; Recruiting
      Robert Wood Johnson AIDS Program, New Brunswick,  New Jersey,  08901-1969,  United States; Recruiting
New York
      Bronx Lebanon Hospital Center, Bronx,  New York,  10457,  United States; Recruiting
      Harlem Hospital, New York,  New York,  10037,  United States; Recruiting
      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States; Recruiting
      University of Rochester Medical Center, Rochester,  New York,  14642-0001,  United States; Recruiting
      Lincoln Medical & Mental Health Center, Bronx,  New York,  10451,  United States; Recruiting
      New York University School of Medicine, New York,  New York,  10016,  United States; Recruiting
      State University of New York at Stony Brook, Stony Brook,  New York,  11794-8111,  United States; Recruiting
      Mt. Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
      Metropolitan Hospital Center, New York,  New York,  10029,  United States; Recruiting
      Jacobi Medical Center, Bronx,  New York,  10461,  United States; Recruiting
      Children's Hospital at Downstate, Brooklyn,  New York,  11203-2098,  United States; Recruiting
North Carolina
      Duke University (Pediatric), Durham,  North Carolina,  27705,  United States; Recruiting
      University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599-7220,  United States; Recruiting
Pennsylvania
      St. Christophers Hosp. for Children. Philadelphia, Philadelphia,  Pennsylvania,  19134,  United States; Recruiting
Tennessee
      St. Jude Childrens Research Hospital, Memphis, Memphis,  Tennessee,  38105-2794,  United States; Recruiting
Texas
      Baylor (Texas Childrens Hospital)(Pediatric), Houston,  Texas,  77030,  United States; Recruiting
Washington
      University of South Flordia, Seattle,  Washington,  98105-0371,  United States; Recruiting
Puerto Rico
      University of Puerto Rico, U. Childrens Hospital AIDS, San Juan,  00936-5067,  Puerto Rico; Recruiting
      San Juan City Hospital, San Juan,  Puerto Rico; Recruiting

Study chairs or principal investigators

Grace Aldrovandi, MD,  Study Chair,  University of Alabama, Birmingham   
Peggy Borum, PhD,  Study Chair,  University of Florida   

Study ID Numbers:  PACTG P1045
Record last reviewed:  March 2005
Last Updated:  April 7, 2005
Record first received:  September 12, 2003
ClinicalTrials.gov Identifier:  NCT00069004
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08