Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006190
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2000-08-25
Brief Title:
A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2010-03
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:
HIV infection is a major global health problem Survival and quality of life for HIV subjects has tremendously improved with the advent of a class of antivirals called protease inhibitors and the utilization of highly active combination therapy However such therapy has been associated with a syndrome called lipodystrophy This lipodystrophy syndrome causes body shape changes typically thinning and loss of fat from the arms legs and face with increased fat appearing in the abdomen and neck There are also metabolic changes which occur and subjects can develop increased triglycerides increased cholesterol and an increased risk for diabetes as indicated by increasing insulin resistance This study will take HIV positive subjects who have not yet started antiviral medications treatment naiveand randomly assign them to one of two treatment arms These treatment arms will be SustivaZeritEpivir vs ViraceptZeritEpivir The subjects will be treated and followed for two years and have extensive metabolic testing skinfold thickness measurements MRI scans and other measures to determine if and how they are experiencing changes in metabolism or body shape and to discover the mechanism of why this occurs Understanding the mechanism should allow researchers to design interventions for subjects who have lipodystrophy and strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the future
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK056583-01 | NIH | None | httpsreporternihgovquickSearchR01DK056583-01 |