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A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
This study is ongoing, but not recruiting participants.
First Received: September 12, 2003   Last Updated: July 28, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00069004
  Purpose

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

Study Type: Observational
Official Title: Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 450
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069004

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham (Pediatric)
Birmingham, Alabama, United States, 35233
United States, California
Children's Hospital, Oakland (Pediatric)
Oakland, California, United States, 94609-1809
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, United States, 94143-0105
Los Angeles County Medical Center/USC
Los Angeles, California, United States, 90033
Childrens Hospital of Orange County
Orange, California, United States, 92868
UCSD Mother, Child & Adolescent HIV Program
San Diego, California, United States, 92103
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
UCLA Medical Center (Pediatric)
Los Angeles, California, United States, 90095-1752
United States, Colorado
Childrens Hospital (U. Colorado Denver)
Denver, Colorado, United States, 80218-1088
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States
Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
North Broward Hospital District
Fort Lauderdale, Florida, United States, 33316
University of Florida, Gainesville
Gainesville, Florida, United States, 32610-0296
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago Childrens Memorial Hospital (pediatric)
Chicago, Illinois, United States, 60614
Womens & Childrens HIV Program
Chicago, Illinois, United States, 60608-1797
University of Illinois
Chicago, Illinois, United States, 60612-7234
United States, Louisiana
Tulane Univ., Charity Hospital of New Orleans
New Orleans, Louisiana, United States, 70112-2699
United States, Maryland
Johns Hopkins University (Pediatric)
Baltimore, Maryland, United States, 21287
University of Maryland (Pediatric)
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115
Boston Medical Center (Pediatric)
Boston, Massachusetts, United States, 02118
United States, Michigan
Childrens Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
University of Med. & Dentistry of NJ/Univ. Hospital
Newark, New Jersey, United States, 07101-1709
Robert Wood Johnson AIDS Program
New Brunswick, New Jersey, United States, 08901-1969
United States, New York
Bronx Lebanon Hospital Center
Bronx, New York, United States, 10457
Harlem Hospital
New York, New York, United States, 10037
Mt. Sinai Medical Center
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14642-0001
Lincoln Medical & Mental Health Center
Bronx, New York, United States, 10451
New York University School of Medicine
New York, New York, United States, 10016
State University of New York at Stony Brook
Stony Brook, New York, United States, 11794-8111
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Metropolitan Hospital Center
New York, New York, United States, 10029
Jacobi Medical Center
Bronx, New York, United States, 10461
Children's Hospital at Downstate
Brooklyn, New York, United States, 11203-2098
United States, North Carolina
Duke University (Pediatric)
Durham, North Carolina, United States, 27705
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7220
United States, Pennsylvania
St. Christophers Hosp. for Children. Philadelphia
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
St. Jude Childrens Research Hospital, Memphis
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Baylor (Texas Childrens Hospital)(Pediatric)
Houston, Texas, United States, 77030
United States, Washington
University of South Flordia
Seattle, Washington, United States, 98105-0371
Puerto Rico
University of Puerto Rico, U. Childrens Hospital AIDS
San Juan, Puerto Rico, 00936-5067
San Juan City Hospital
San Juan, Puerto Rico
Sponsors and Collaborators
Investigators
Study Chair: Grace Aldrovandi, MD University of Alabama at Birmingham
Study Chair: Peggy Borum, PhD University of Florida
  More Information

Additional Information:
Publications:
Study ID Numbers: PACTG P1045
Study First Received: September 12, 2003
Last Updated: July 28, 2008
ClinicalTrials.gov Identifier: NCT00069004     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-Associated Lipodystrophy Syndrome
HIV Lipodystrophy Syndrome
Treatment Experienced
Lipodystrophy
Dyslipidemia
Osteoporosis
Osteopenia

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Infection
Bone Diseases
Pathologic Processes
Musculoskeletal Diseases
Syndrome
Lipodystrophy
Congenital Abnormalities
Retroviridae Infections
Dyslipidemias
RNA Virus Infections
Disease
Metabolic Diseases
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Osteoporosis
Bone Diseases, Metabolic
Immunologic Deficiency Syndromes
Virus Diseases
HIV-Associated Lipodystrophy Syndrome
HIV Infections
Skin Diseases, Metabolic
Sexually Transmitted Diseases
Lentivirus Infections
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 22, 2009