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Metformin and Systemic Inflammation in HIV | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Metformin and Systemic Inflammation in HIV

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

NCT03774108•Hospital Civil de Guadalajara

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Hospital Civil de Guadalajara

Guadalajara, Jalisco, Mexico

Key Dates

Start Date

December 15, 2018

Primary Completion Date

December 20, 2019

Completion Date

January 8, 2020

Last Updated

December 19, 2019

Enrollment

ACTUAL participants

Conditions

PreDiabetesHIV-1-infection

Interventions

Metformin Hydrochloride 850 MG

DRUG

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metformin and Systemic Inflammation in HIV

Inclusion Criteria

Exclusion Criteria

Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

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