Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-03-08 @ 5:56 AM
Study NCT ID:
NCT03774108
Status:
UNKNOWN
Last Update Posted:
2019-12-19
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin and Systemic Inflammation in HIV
Sponsor:
Hospital Civil de Guadalajara
Organization:
Study Overview
Official Title:
Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
ACTIVE_NOT_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:
Metfo
Brief Summary:
The purposes of this study are to find out if: metformin can be combined with anti-HIV drugs to reduce systemic inflammation measured by the determination of cytokines and other series of serum markers. To determine if the concomitant administration of metformin with TARA improves the immune function on the CD4 T cell count and its relation with the CD8 T cells, during the treatment and after its interruption.
To this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable TARA and with a CD4 + level\> 200 cells / μL.
40 patients from the HIV Unit of the Civil Hospital of Guadalajara "Fray Antonio Alcalde" will be included in this study and the intervention will last 8 weeks.
To this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable TARA and with a CD4 + level\> 200 cells / μL.
40 patients from the HIV Unit of the Civil Hospital of Guadalajara "Fray Antonio Alcalde" will be included in this study and the intervention will last 8 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: