Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001142
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Metabolism and Body Shape of Healthy Children and Children With Chronic Infections
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Metabolism and Body Composition of Healthy Children and Children With Chronic Infections
Status:
COMPLETED
Status Verified Date:
2000-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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 unmasked by the longevity achieved by those treated with protease inhibitors remains uncertain It has been suggested although not proven that this condition may be an adverse effect of protease inhibitor treatment It is also unknown whether HIV-infected children develop significant lipodystrophy when exposed to protease inhibitors We propose to investigate whether initiation of protease inhibitor-containing antiretroviral regimens in children with HIV infection affects the prevalence of dyslipidemia insulin resistance and alterations of body fat distribution and to study the pathophysiology of these changes The incidence of such abnormalities will be compared to children with non-HIV-related chronic infections to HIV-infected children who are treated with protease inhibitor sparing regimen and to healthy controls
This study has both cross-sectional and longitudinal components Children with HIV infection who are to begin taking protease inhibitors and who are already taking protease inhibitors as part of their treatment for HIV infection will be recruited for a single cross-sectional evaluation that will include studies of lipid and glucose metabolism and body composition In the longitudinal component those children with HIV infection who were studied before they began taking protease inhibitors will be followed prospectively for 18 months to delineate further the relationships between treatment and the development of lipodystrophy and abnormalities in lipid and glucose metabolism If the cross-sectional study does not show that the prevalence of lipodystrophy and its associated metabolic alterations increases as a function of exposure to protease inhibitors we will terminate the prospective study Changes in triglyceride levels insulin levels and regional body fat will be evaluated as primary outcome measures As part of the evaluations performed during the cross-sectional and longitudinal studies we will investigate the pathophysiology of dyslipidemia in HIV-infected children by assessing lipoproteins and their subclasses apolipoproteins and both lipoprotein lipase levels and activity
This study has both cross-sectional and longitudinal components Children with HIV infection who are to begin taking protease inhibitors and who are already taking protease inhibitors as part of their treatment for HIV infection will be recruited for a single cross-sectional evaluation that will include studies of lipid and glucose metabolism and body composition In the longitudinal component those children with HIV infection who were studied before they began taking protease inhibitors will be followed prospectively for 18 months to delineate further the relationships between treatment and the development of lipodystrophy and abnormalities in lipid and glucose metabolism If the cross-sectional study does not show that the prevalence of lipodystrophy and its associated metabolic alterations increases as a function of exposure to protease inhibitors we will terminate the prospective study Changes in triglyceride levels insulin levels and regional body fat will be evaluated as primary outcome measures As part of the evaluations performed during the cross-sectional and longitudinal studies we will investigate the pathophysiology of dyslipidemia in HIV-infected children by assessing lipoproteins and their subclasses apolipoproteins and both lipoprotein lipase levels and activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CH-0010 | None | None | None |