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Metformin and Systemic Inflammation in HIV (Metfo)

Primary Purpose

PreDiabetes, HIV-1-infection

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Metformin Hydrochloride 850 MG
Placebo
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Civil de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin Experimental Arm

Placebo Comparator Arm

Arm Description

Metformin 850mg/12 hours, oral, 8 weeks

Placebo pills/12hours, oral, 8 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 10, 2018
Last Updated
December 17, 2019
Sponsor
Hospital Civil de Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT03774108
Brief Title
Metformin and Systemic Inflammation in HIV
Acronym
Metfo
Official Title
Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Anticipated)
Study Completion Date
January 8, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, HIV-1-infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin Experimental Arm
Arm Type
Experimental
Arm Description
Metformin 850mg/12 hours, oral, 8 weeks
Arm Title
Placebo Comparator Arm
Arm Type
Placebo Comparator
Arm Description
Placebo pills/12hours, oral, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin Hydrochloride 850 MG
Intervention Description
8 weeks tratment with oral metformin
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
8 weeks tratment with oral placebo
Primary Outcome Measure Information:
Title
Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin
Description
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
Time Frame
Basal - 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Civil de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from participants will be available upon reasonable request
IPD Sharing Time Frame
Basal - 8 weeks
Citations:
PubMed Identifier
27766258
Citation
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.
Results Reference
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PubMed Identifier
29773933
Citation
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.
Results Reference
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PubMed Identifier
27058351
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.
Results Reference
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PubMed Identifier
25772174
Citation
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.
Results Reference
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Metformin and Systemic Inflammation in HIV

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