Healthy Clinical Trial
Official title:
Metabolism and Body Composition of Healthy Children and Children With Chronic Infections
Some HIV-infected adults develop lipodystrophy that includes significant changes in body
shape, with fat losses in the face, arms and legs, and fat gain in the trunk. This
lipodystrophy is often accompanied by other disorders of metabolism, such as increased
levels of fat and insulin in the blood.
The majority of these cases have been seen when patients are taking medications called
protease inhibitors. These are anti-retroviral medications designed to treat patients with
HIV. It is unclear if lipodystrophy is a result of having HIV or the medication used to
treat HIV. It has been suggested, but not proven, that lipodystrophy is a direct side effect
of protease inhibitors. In addition, it is unknown if HIV-infected children develop
significant lipodystrophy after taking protease inhibitors.
This study will investigate the prevalence of metabolic disorders and changes in body fat
distribution in children taking protease inhibitor anti-retroviral medications. The results
will be compared to three other groups; (1) children suffering from other non-HIV chronic
infections, (2) HIV-infected children not taking protease inhibitors, and (3) healthy
children.
The study will look at HIV-infected children who have already started taking protease
inhibitors. It will evaluate these children for disorders in metabolism as well as body fat
changes. In addition, the study will follow HIV-infected children who will begin taking
protease inhibitors. The study will follow these children for 18 months to detect the
development of disorders in metabolism and / or body fat changes.
Status | Completed |
Enrollment | 185 |
Est. completion date | December 2000 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Child Health and Human Development (NICHD) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Carr A, Samaras K, Burton S, Law M, Freund J, Chisholm DJ, Cooper DA. A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS. 1998 May 7;12(7):F51-8. — View Citation
Lo JC, Mulligan K, Tai VW, Algren H, Schambelan M. "Buffalo hump" in men with HIV-1 infection. Lancet. 1998 Mar 21;351(9106):867-70. — View Citation
Miller KD, Jones E, Yanovski JA, Shankar R, Feuerstein I, Falloon J. Visceral abdominal-fat accumulation associated with use of indinavir. Lancet. 1998 Mar 21;351(9106):871-5. — View Citation
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