Metformin and Systemic Inflammation in HIV

Study Overview
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Brief Summary
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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.

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

Conditions
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PreDiabetes, HIV-1-infection

Intervention / Treatment
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* Drug: Metformin Hydrochloride 850 MG
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin Experimental Arm<br>Metformin 850mg/12 hours, oral, 8 weeks | Drug: Metformin Hydrochloride 850 MG<br>* 8 weeks tratment with oral metformin<br>|
| Placebo Comparator: Placebo Comparator Arm<br>Placebo pills/12hours, oral, 8 weeks | Other: Placebo<br>* 8 weeks tratment with oral placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin | Serum levels of proinflammatory cytokines will be quantify by flow cytometry using a Cytometric Bead Array. The cytokine panel to be messured will be as follows: IL-1beta IFN-alpha2 IFN-gamma TNF-alpha MCP-1 IL-6 IL-8 IL-10 IL-12p70 IL-17A IL-18 IL-23 IL-33 These cytokines will be quantify in prediabetic HIV positive patients after 8 weeks treatment with Metformin | Basal - 8 weeks |