Metformin and Systemic Inflammation in HIV

PreDiabetes Clinical Trial

— Metfo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03774108
• Other study ID #: 114/18
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 15, 2018
• Est. completion date: January 8, 2020

Study information

• Verified date: December 2019
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 8, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection
• Inflammation
• PreDiabetes
• Prediabetic State

Intervention

Drug:
• Metformin Hydrochloride 850 MG
8 weeks tratment with oral metformin

Other:
• Placebo
8 weeks tratment with oral placebo

Locations

Country	Name	City	State
Mexico	Hospital Civil de Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

Saisho Y. Metformin and Inflammation: Its Potential Beyond Glucose-lowering Effect. Endocr Metab Immune Disord Drug Targets. 2015;15(3):196-205. Review. — View Citation

Slim J, Saling CF. A Review of Management of Inflammation in the HIV Population. Biomed Res Int. 2016;2016:3420638. Epub 2016 Sep 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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