Clinical trial NCT03774108: Metformin and Systemic Inflammation in HIV
Official title: Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PreDiabetes
HIV-1-infection
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin
timeFrame: Basal - 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara
state: Jalisco
Study officials:
References:
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.
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.
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.
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.