Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367744
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2006-08-21
Brief Title:
Rosiglitazone Effect on Mitochondria and Lipoatrophy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy
Status:
COMPLETED
Status Verified Date:
2006-08
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:
The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine d4T or zidovudine AZT
Detailed Description:
This is a phase II randomized double-blind placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy Subjects will receive blinded study treatment for 48 weeks This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT The study also will assess the safety and tolerability of rosiglitazone in this population and its effect on carotid IMT prevalence of metabolic syndrome lipid parameters and glucose metabolism
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 |
|---|---|---|---|
| AI060484-C | OTHER_GRANT | NIAID | None |