Status:
UNKNOWN
Metformin and Systemic Inflammation in HIV
Lead Sponsor:
Hospital Civil de Guadalajara
Conditions:
PreDiabetes
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 marker...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03774108
Start Date
December 15 2018
End Date
January 8 2020
Last Update
December 19 2019
Active Locations (1)
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1
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico, 44280