Metformin and Systemic Inflammation in HIV

NCT03774108 | Unknown Phase 4

• 1 other identifier: 114/18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Metformin Experimental Arm

EXPERIMENTAL

Metformin 850mg/12 hours, oral, 8 weeks

Drug: Metformin Hydrochloride 850 MG

Placebo Comparator Arm

PLACEBO COMPARATOR

Placebo pills/12hours, oral, 8 weeks

Other: Placebo

Interventions

Metformin Hydrochloride 850 MG DRUG

8 weeks tratment with oral metformin

Metformin Experimental Arm

Placebo OTHER

8 weeks tratment with oral placebo

Placebo Comparator Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (4)

• Slim J, Saling CF. A Review of Management of Inflammation in the HIV Population. Biomed Res Int. 2016;2016:3420638. doi: 10.1155/2016/3420638. Epub 2016 Sep 27.

  PMID: 27766258 BACKGROUND

• Arafath S, Campbell T, Yusuff J, Sharma R. Prevalence of and Risk Factors for Prediabetes in Patients Infected With HIV. Diabetes Spectr. 2018 May;31(2):139-143. doi: 10.2337/ds17-0009.

  PMID: 29773933 BACKGROUND

• Nou E, Lo J, Grinspoon SK. Inflammation, immune activation, and cardiovascular disease in HIV. AIDS. 2016 Jun 19;30(10):1495-509. doi: 10.1097/QAD.0000000000001109.

  PMID: 27058351 BACKGROUND

• Saisho Y. Metformin and Inflammation: Its Potential Beyond Glucose-lowering Effect. Endocr Metab Immune Disord Drug Targets. 2015;15(3):196-205. doi: 10.2174/1871530315666150316124019.

  PMID: 25772174 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: December 15, 2018
• Primary Completion: December 20, 2019
• Study Completion: January 8, 2020
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Basal - 8 weeks

Locations

ME (1)