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

NCT00001142 | Completed

• 2 other identifiers: 00001000-CH-0010
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; Healthy; Hyperlipidemia; Lipodystrophy

Keywords

Body Fat; DXA; HAART; Hyperlipidemia; Insulin Resistance; Lipodystrophy; MRI; Protease Inhibitor; Side-Effects; Visceral Fat; Chronic Infection; HIV; Healthy Volunteer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1097/00002030-199807000-00003.

  PMID: 9619798 BACKGROUND

• 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. doi: 10.1016/S0140-6736(97)11443-X.

  PMID: 9525364 BACKGROUND

• 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. doi: 10.1016/S0140-6736(97)11518-5.

  PMID: 9525365 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Hyperlipidemias; Lipodystrophy; Insulin Resistance; Persistent Infection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: October 1, 1999
• Study Completion: December 1, 2000
• Last Updated: March 4, 2008

Record last verified: 2000-10

Locations

US (1)