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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 16, 2003
Last Update Posted: January 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
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).

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
Study Start Date: October 2003
Study Completion Date: August 2005
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069004

  Show 38 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Grace Aldrovandi, MD University of Alabama at Birmingham
Study Chair: Peggy Borum, PhD University of Florida
  More Information

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.
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. Epub 2001 Dec 7. Review.
Smith KY. Selected metabolic and morphologic complications associated with highly active antiretroviral therapy. J Infect Dis. 2002 May 15;185 Suppl 2:S123-7. Review.
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.
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.
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.
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.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00069004     History of Changes
Other Study ID Numbers: P1045
10108 ( Registry Identifier: DAIDS ES )
First Submitted: September 12, 2003
First Posted: September 16, 2003
Last Update Posted: January 7, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
HIV Infections
Bone Diseases, Metabolic
HIV-Associated Lipodystrophy Syndrome
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Bone Diseases
Musculoskeletal Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases

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