Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225082
Status:
COMPLETED
Last Update Posted:
2010-10-05
First Post:
2005-09-21
Brief Title:
SNAP Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
SNAP Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial
Status:
COMPLETED
Status Verified Date:
2010-10
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:
HIV infected subjects receiving antiretroviral treatment for greater than 6 years with be evaluated for clinical lipoatrophy and mitochondrial function after switching nucleoside analogues from stavudine d4T to tenofovir treatment and after 4
Hypothesis Tenofovir therapy will increase peripheral fat content as assessed by DEXA and mitochondrial function at 48 weeks
Hypothesis Tenofovir therapy will increase peripheral fat content as assessed by DEXA and mitochondrial function at 48 weeks
Detailed Description:
HIV infected subjects receiving antiretroviral treatment lopinavirritonavir stavudine and lamivudine for greater than 6 years through the Abbott M97-720 protocol with be evaluated for clinical lipoatrophy and mitochondrial function prior to switching nucleoside analogues from stavudine d4T to tenofovir and after 48 weeks or tenofovir treatment
Subjects with or without lipoatrophy are eligible for the study Adipose tissue biopsies to measure mitochondrial function metabolic laboratory tests and DAXA scans and clinical evaluations of lipodystrophy will be performed at Entry and after 48 weeks of tenofovir treatment
Subjects with or without lipoatrophy are eligible for the study Adipose tissue biopsies to measure mitochondrial function metabolic laboratory tests and DAXA scans and clinical evaluations of lipodystrophy will be performed at Entry and after 48 weeks of tenofovir treatment
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