Metformin and Systemic Inflammation in HIV

Phase 4

• Conditions: HIV-1-infection; PreDiabetes
• Interventions: Other: Placebo; Drug: Metformin Hydrochloride 850 MG

• Registration Number: NCT03774108
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Study Start: 2018-12-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-19
• Primary Completion: 2019-12-20
• Study Completion: 2020-01-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator Arm	Placebo	Placebo pills/12hours, oral, 8 weeks
Metformin Experimental Arm	Metformin Hydrochloride 850 MG	Metformin 850mg/12 hours, oral, 8 weeks

Primary Outcome Measures

Name	Time	Method
Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin	Basal - 8 weeks	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

Trial Locations

Locations (1)

Hospital Civil de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico