Metformin and Systemic Inflammation in HIV (Metfo)
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|ClinicalTrials.gov Identifier: NCT03774108|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2018
Last Update Posted : December 19, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
8 weeks tratment with oral placebo
- 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:
These cytokines will be quantify in prediabetic HIV positive patients after 8 weeks treatment with Metformin
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
|Hospital Civil de Guadalajara|
|Guadalajara, Jalisco, Mexico, 44280|