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Metformin and Systemic Inflammation in HIV (Metfo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774108
Recruitment Status : Active, not recruiting
First Posted : December 12, 2018
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Moises Ramos Solano, 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.


Condition or disease Intervention/treatment Phase
PreDiabetes HIV-1-infection Drug: Metformin Hydrochloride 850 MG Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : January 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Prediabetes

Arm Intervention/treatment
Experimental: Metformin Experimental Arm
Metformin 850mg/12 hours, oral, 8 weeks
Drug: Metformin Hydrochloride 850 MG
8 weeks tratment with oral metformin

Placebo Comparator: Placebo Comparator Arm
Placebo pills/12hours, oral, 8 weeks
Other: Placebo
8 weeks tratment with oral placebo




Primary Outcome Measures :
  1. Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin [ Time Frame: 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774108


Locations
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Mexico
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico, 44280
Sponsors and Collaborators
Hospital Civil de Guadalajara
Publications:
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Responsible Party: Moises Ramos Solano, Associate professor, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT03774108    
Other Study ID Numbers: 114/18
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from participants will be available upon reasonable request
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Basal - 8 weeks

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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
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs