search
Back to results

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

Primary Purpose

HIV Infections, HIV-Associated Lipodystrophy Syndrome, HIV Lipodystrophy Syndrome

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring HIV-Associated Lipodystrophy Syndrome, HIV Lipodystrophy Syndrome, Treatment Experienced, Lipodystrophy, Dyslipidemia, Osteoporosis, Osteopenia

Eligibility Criteria

7 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UAB, Dept. of Ped., Div. of Infectious Diseases
  • Usc La Nichd Crs
  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • UCSD Mother-Child-Adolescent Program CRS
  • UCSF Pediatric AIDS CRS
  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Colorado Denver NICHD CRS
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • Children's National Med. Ctr., ACTU
  • Howard Univ. Washington DC NICHD CRS
  • South Florida CDTC Ft Lauderdale NICHD CRS
  • Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
  • USF - Tampa NICHD CRS
  • Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
  • Chicago Children's CRS
  • Tulane/LSU Maternal/Child CRS
  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
  • Rutgers - New Jersey Medical School CRS
  • Lincoln Med. & Mental Health Ctr.
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • Jacobi Med. Ctr.
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • Nyu Ny Nichd Crs
  • Metropolitan Hosp. Ctr.
  • Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • SUNY Stony Brook NICHD CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
  • DUMC Ped. CRS
  • St. Jude/UTHSC CRS
  • Texas Children's Hosp. CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
  • San Juan City Hosp. PR NICHD CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2003
Last Updated
January 6, 2014
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00069004
Brief Title
A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
Official Title
Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth
Study Type
Observational

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV-Associated Lipodystrophy Syndrome, HIV Lipodystrophy Syndrome, Lipodystrophy, Dyslipidemia, Osteoporosis, Osteopenia
Keywords
HIV-Associated Lipodystrophy Syndrome, HIV Lipodystrophy Syndrome, Treatment Experienced, Lipodystrophy, Dyslipidemia, Osteoporosis, Osteopenia

7. Study Design

Enrollment
450 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Aldrovandi, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peggy Borum, PhD
Organizational Affiliation
University of Florida
Official's Role
Study Chair
Facility Information:
Facility Name
UAB, Dept. of Ped., Div. of Infectious Diseases
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Usc La Nichd Crs
City
Alhambra
State/Province
California
ZIP/Postal Code
91803
Country
United States
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
UCSD Mother-Child-Adolescent Program CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Children's National Med. Ctr., ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard Univ. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
South Florida CDTC Ft Lauderdale NICHD CRS
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Facility Name
USF - Tampa NICHD CRS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901-1969
Country
United States
Facility Name
Rutgers - New Jersey Medical School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Lincoln Med. & Mental Health Ctr.
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Bronx-Lebanon Hosp. IMPAACT CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Jacobi Med. Ctr.
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Nyu Ny Nichd Crs
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Metropolitan Hosp. Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Harlem Hosp. Ctr. NY NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8111
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7220
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
St. Jude/UTHSC CRS
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
11740715
Citation
Wanke CA, Falutz JM, Shevitz A, Phair JP, Kotler DP. Clinical evaluation and management of metabolic and morphologic abnormalities associated with human immunodeficiency virus. Clin Infect Dis. 2002 Jan 15;34(2):248-59. doi: 10.1086/324744. Epub 2001 Dec 7.
Results Reference
background
PubMed Identifier
12001033
Citation
Smith KY. Selected metabolic and morphologic complications associated with highly active antiretroviral therapy. J Infect Dis. 2002 May 15;185 Suppl 2:S123-7. doi: 10.1086/340200.
Results Reference
background
PubMed Identifier
11966241
Citation
Currier J, Carpenter C, Daar E, Kotler D, Wanke C. Identifying and managing morphologic complications of HIV and HAART. AIDS Read. 2002 Mar;12(3):114-9, 124-5.
Results Reference
background
PubMed Identifier
10382692
Citation
Carr A, Samaras K, Thorisdottir A, Kaufmann GR, Chisholm DJ, Cooper DA. Diagnosis, prediction, and natural course of HIV-1 protease-inhibitor-associated lipodystrophy, hyperlipidaemia, and diabetes mellitus: a cohort study. Lancet. 1999 Jun 19;353(9170):2093-9. doi: 10.1016/S0140-6736(98)08468-2.
Results Reference
background
PubMed Identifier
12797313
Citation
Bockhorst JL, Ksseiry I, Toye M, Chipkin SR, Stechenberg BW, Fisher DJ, Allen HF. Evidence of human immunodeficiency virus-associated lipodystrophy syndrome in children treated with protease inhibitors. Pediatr Infect Dis J. 2003 May;22(5):463-5.
Results Reference
background
PubMed Identifier
10770534
Citation
Tebas P, Powderly WG, Claxton S, Marin D, Tantisiriwat W, Teitelbaum SL, Yarasheski KE. Accelerated bone mineral loss in HIV-infected patients receiving potent antiretroviral therapy. AIDS. 2000 Mar 10;14(4):F63-7. doi: 10.1097/00002030-200003100-00005.
Results Reference
background
PubMed Identifier
20168204
Citation
Jacobson DL, Lindsey JC, Gordon CM, Moye J, Hardin DS, Mulligan K, Aldrovandi GM; Pediatric AIDS Clinical Trials Group P1045 team. Total body and spinal bone mineral density across Tanner stage in perinatally HIV-infected and uninfected children and youth in PACTG 1045. AIDS. 2010 Mar 13;24(5):687-96. doi: 10.1097/QAD.0b013e328336095d.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs