Search / Trial NCT00001142

Metabolism and Body Shape of Healthy Children and Children With Chronic Infections

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Dec 9, 2002

Apply for Trial

Trial Information

Current as of June 13, 2024

Completed

Keywords

Body Fat Dxa Haart Hyperlipidemia Insulin Resistance Lipodystrophy Mri Protease Inhibitor Side Effects Visceral Fat Chronic Infection Hiv Healthy Volunteer

Description

Some HIV-infected adults develop a lipodystrophy that includes significant changes in body shape, with fat loss in the face, arms and legs, and fat gain in the trunk. This lipodystrophy is often accompanied by hypertriglyceridemia, hypercholesterolemia, and hyperinsulinemia. So far, almost all cases of lipodystrophy have occurred in patients treated with protease inhibitor-containing antiretroviral therapies. Whether this lipodystrophy is a result of the use of protease inhibitors or other therapies employed for HIV infection, or is one of the many manifestations of HIV infection, and is un...

Gender

All

Eligibility criteria

  • FOR PROTEASE INHIBITOR-NAIVE HIV-INFECTED CHILDREN AND HIV-INFECTED CHILDREN ON PROTEASE INHIBITOR-CONTAINING ANTIRETROVIRAL REGIMENS:
  • Evidence of HIV infection based on Center for Disease Control and Prevention criteria.
  • Enrollment on protocol 98-C-0041 or other HIV treatment protocol for children.
  • No other chronic disease unrelated to infection that may cause changes in body composition or in lipid or glucose homeostasis.
  • No previous use of a protease inhibitor-containing antiretroviral regimen (PROTEASE INHIBITOR-NAIVE HIV-INFECTED CHILDREN ONLY).
  • Data available concerning the start date of protease inhibitor treatment (HIV-INFECTED CHILDREN ON PROTEASE INHIBITOR-CONTAINING ANTIRETROVIRAL REGIMENS ONLY).
  • HEALTHY PEDIATRIC VOLUNTEERS:
  • Good general health. No significant hematologic, renal, hepatic, endocrinologic, or pulmonary disorders.
  • No evidence of HIV infection by standard HIV antibody testing.
  • Body mass index for age below 85th percentile.
  • Not currently using prescription medications on a continuing basis; the use of over-the-counter medications will be reviewed on a case-by-case basis.
  • Stable clinical condition during evaluation.
  • CHILDREN WITH CONDITIONS CAUSING CHRONIC INFECTIONS OTHER THAN HIV:
  • Evidence of chronic, non-HIV-related infection such as chronic granulomatous disease, hyperimmunoglobin E syndrome, etc.
  • Evidence of non-growth hormone-deficient growth failure, defined as a 12-month height velocity at or below the fifth percentile for age using standard reference norms and by clinically-indicated testing.
  • No evidence of HIV infection by standard HIV antibody testing.
  • No current (last 2 months) use of sex steroid supplementation.
  • Enrollment in an ongoing NIH protocol for treatment of their disorders.
  • Age between 4 and 18 years.
  • No other chronic disease unrelated to infection that may cause either changes in body composition or lipid or glucose homeostasis such as Type I diabetes mellitus, lipodystrophic diabetes, Cushing's syndrome etc.
  • No pregnancy.
  • No inability to undergo MRI because of metal objects within their bodies that are contraindications for MRI. These include cardiac pacemakers, neural pacemakers, aneurysmal clips, schrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or electromechanical devices.
  • No allergic reaction to heparin.

Attachments

readout_NCT00001142_2024-06-13.pdf

4.5 MB

NCT00001142_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0