A double blinded, phase II, placebo controlled, single centre randomized clinical trial to evaluate Metformin compared with placebo for reversal of accelerated biological aging in persons living with HIV 50 years or older and with suppressed virologic replication.

Conditions

HIV infection

Brief summary

EAA difference by Phenoage epigenetic clock

Detailed description

EAA difference by Horvath´s clock, Hannum´s clock, GrimAge and PhenoAge, Immune profile: % and absolute number of CD4+ T cells, CD8+ T cells, CD4+/CD8+ ratio, haematopoietic progenitors, CD4+ and CD8+ T-cell subsets (recent thymic emigrants, naïve, central and effector memory, TEMRA, activated, exhausted and senescent), T-reg, B-cell subsets (naïve, class-switched memory, non-class switched memory), NK subsets (CD56dim CD16hi, CD56hi CD16-/low) and monocytes (classic, non-classic and intermediate), Changes in the inflammatory markers: IL-6, CRP, D-Dimer, Changes in Telomere length in PBMC, Changes in the following aging biomarkers:  TAME biomarkers: IL-6, TNFR II, hsCRP, GDF15, IGF-1, fasting insulin, cystatin C; NT-proBNP, haemoglobin A1c. Oxidative stress and DNA damage: reactive oxygen species (ROS), catalase expression, superoxide dismutase 1 - 2 levels, γH2AX histone levels. Other inflammatory and pro-coagulant biomarkers: IL-1 beta, TNF-alfa, D-dimer, Changes in the following Frailty battery: Fried frailty index, grip strength, walking speed and short physical performance battery, Changes in creatinine, Changes in integrated and total (Gag) HIV-DNA. Changes in CA US HIV-RNA. Changes in intact proviral DNA

Related papers

No related papers found yet.

Interventions

DRUGMetformina Pensa Pharma 850 mg comprimidos recubiertos con película EFG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
EAA difference by Phenoage epigenetic clock	—

Secondary

Measure	Time frame
EAA difference by Horvath´s clock, Hannum´s clock, GrimAge and PhenoAge, Immune profile: % and absolute number of CD4+ T cells, CD8+ T cells, CD4+/CD8+ ratio, haematopoietic progenitors, CD4+ and CD8+ T-cell subsets (recent thymic emigrants, naïve, central and effector memory, TEMRA, activated, exhausted and senescent), T-reg, B-cell subsets (naïve, class-switched memory, non-class switched memory), NK subsets (CD56dim CD16hi, CD56hi CD16-/low) and monocytes (classic, non-classic and intermediate), Changes in the inflammatory markers: IL-6, CRP, D-Dimer, Changes in Telomere length in PBMC, Changes in the following aging biomarkers:  TAME biomarkers: IL-6, TNFR II, hsCRP, GDF15, IGF-1, fasting insulin, cystatin C; NT-proBNP, haemoglobin A1c. Oxidative stress and DNA damage: reactive oxygen species (ROS), catalase expression, superoxide dismutase 1 - 2 levels, γH2AX histone levels. Other inflammatory and pro-coagulant biomarkers: IL-1 beta, TNF-alfa, D-dimer, Changes in the following Fr	—

Measure

Time frame

EAA difference by Horvath´s clock, Hannum´s clock, GrimAge and PhenoAge, Immune profile: % and absolute number of CD4+ T cells, CD8+ T cells, CD4+/CD8+ ratio, haematopoietic progenitors, CD4+ and CD8+ T-cell subsets (recent thymic emigrants, naïve, central and effector memory, TEMRA, activated, exhausted and senescent), T-reg, B-cell subsets (naïve, class-switched memory, non-class switched memory), NK subsets (CD56dim CD16hi, CD56hi CD16-/low) and monocytes (classic, non-classic and intermediate), Changes in the inflammatory markers: IL-6, CRP, D-Dimer, Changes in Telomere length in PBMC, Changes in the following aging biomarkers:  TAME biomarkers: IL-6, TNFR II, hsCRP, GDF15, IGF-1, fasting insulin, cystatin C; NT-proBNP, haemoglobin A1c. Oxidative stress and DNA damage: reactive oxygen species (ROS), catalase expression, superoxide dismutase 1 - 2 levels, γH2AX histone levels. Other inflammatory and pro-coagulant biomarkers: IL-1 beta, TNF-alfa, D-dimer, Changes in the following Fr

—

Countries

Spain

Outcome results

None listed