Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04500678
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2020-07-31
Brief Title:
Impact of Metformin on Immuno-virologic Parameters in HIV
Sponsor:
University of Hawaii
Organization:
University of Hawaii
Study Overview
Official Title:
A 72 Week Randomized Open-label vs Observation Study to Assess the Potential Immuno-virologic Benefit of Metformin in HIV-infected Individuals Receiving Antiretroviral Therapy
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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:
Non-diabetic aviremic HIV-infected individuals on antiretroviral therapy ART will be randomized to metformin therapy or to observation for 72 weeks Primary objective is to assess change over 72 weeks in CD4 T cell negative checkpoint receptors PD-1 and TIGIT As secondary objectives the study will look at 72 week change in other immuno-virologic parameters CD8 T cell negative checkpoint receptors plasma indoleamine 23-dioxygenase IDO levels and CD4 T cell and monocyte intracellular HIV DNA and HIV RNA The study will also explore the 72 week impact of metformin on change in carotid intima-media thickness cIMT as a surrogate marker of atherosclerosis on neuropsychological NP performance strength and change in body composition
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None