NCT03774108

Metformin and Systemic Inflammation in HIV

Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hospital Civil de Guadalajara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PreDiabetes
• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride 850 MG	8 weeks tratment with oral metformin
OTHER	Placebo	8 weeks tratment with oral placebo

Timeline

• Start date: 2018-12-15
• Primary completion: 2019-12-20
• Completion: 2020-01-08
• First posted: 2018-12-12
• Last updated: 2019-12-19

Locations

1 site across 1 country: Mexico