Metformin and Systemic Inflammation in HIV

Hospital Civil de Guadalajara

Status and phase

Unknown

Phase 4

Conditions

HIV-1-infection

PreDiabetes

Treatments

Other: Placebo

Drug: Metformin Hydrochloride 850 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT03774108

114/18

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Both sexes,
Age ≥18 years of age
With a diagnosis of HIV-1 infection,
That they are receiving TARE for at least 12 months (time necessary to establish a stable reservoir),
Patients with undetectable viral load (<40 copies / mL) for at least 12 months,
Have a CD4 + level> 200 cells / μL,
That they do not have a diagnosis of co-infection with HCV or HBV,
Patients who do not have a severe alcohol intake (<21 glasses / week in men and <14 glasses / week in women),
Patients who do not use drugs during the last 90 days prior to the screening visit, or during the study,
Who wish to participate voluntarily in the study and give their written consent.

Exclusion criteria

Individuals with a known hypersensitivity / allergy to metformin.
Patients with contraindications to the use of metformin *.
Individuals who are actively involved in an experimental therapy study or who have received experimental therapy in the last 6 months.
People suffering from stage IV-V chronic kidney disease, uncontrolled heart failure or active infections.
Individuals with diabetes mellitus (according to the criteria of the American Diabetes Association *).
Patients with indication for the use of statins, aspirin or immunomodulators.