Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01461876
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2011-10-10
Brief Title:
Obesity in HIV After Antiretroviral Therapy
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Changes in OverweightObesity Status hsCRP and D-dimer in HIV-infected Patients After 12 Months of Initial Antiretroviral Treatment
Status:
COMPLETED
Status Verified Date:
2014-05
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:
This is a retrospective longitudinal study that evaluates the prevalence and incidence of overweightobesity within an HIV-infected population before and after 12 and 24 months of a stable antiretroviral therapy ART The study group will be compared to the weight of a healthy matched population that is not infected with HIV The primary hypothesis states that the proportion of HIV-infected persons newly classified as overweightobese will increase by 20 after 12 months of initial ART and this incidence will be greater than that of a matched HIV-uninfected control population The effect of immune function variables such as CD4 HIV viral load and ART regimen on weight will be analyzed In addition the study will analyze the effect of weight and immune function markers on the inflammatory markers high sensitivity C-reactive protein hsCRP and D-dimer An HIV samples repository will be used for specimens to be assayed for hsCRP and D-dimer
Detailed Description:
None
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