2024-512287-54-00招募中4 期
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.
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz, Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- EAA difference by Phenoage epigenetic clock
研究概览
简要总结
To evaluate the anti-aging effect of metformin compared to placebo as assessed by difference in epigenetic age acceleration (EAA) by Phenoage at week 96
研究设计
- 分配方式
- Randomized
- 主要目的
- A Double Blinded, Phase Ii, Placebo Controlled, Single Center Randomized Clinical Trial.
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be 50 years old or older, at the time of signing the informed consent.
- •Participants with HIV-1 infection and an uninterrupted ART regimen in the 3 months prior to study entry a. Only switch for tolerability/convenience/access reasons to generic drugs or switch from ritonavir to cobicistat would be allowed in the 3-month window and as long as the components of the regimen are unchanged.
- •HIV viral load (VL) <50 copies/mL at screening and in the year prior to study entry. a. A blip (50-200 copies/ml) would be allowed within 12 months prior to inclusion in the study, if preceded and followed by an undetectable VL determination.
- •CD4 count > 500 cel/μL at screening.
- •Participants with normal vitamin B12 levels at screening
- •Participants with normal HOMA-IR (≤ 2.6)
- •Body mass index (BMI) less than 30 Kg/m
- •Female participants with suspected or documented menopause a. Peri- or post-menopausal, defined as having no menstrual periods for at least 12 months prior to study entry, or skipping at least one menstrual period in the 12 months prior to study entry. Peri- or post-menopausal status will be determined for candidates who have had the uterus removed by an assessment of blood follicle stimulating hormone
- •Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participants previously diagnosed with diabetes mellitus, prediabetes and body mass index > 30 kg/m
- •Impaired renal function (estimated glomerular filtration rate <60 mL/min).
- •Liver laboratory abnormalities: alanine aminotransferase (ALT) over 5 times the upper limit of normal (ULN) or ALT over 3xULN and bilirubin over 1.5xULN or any verified Grade 4 laboratory abnormality that to the investigators criteria would affect the safety of the participant if included in the study.
- •Pregnant or breastfeeding women, women wishing to conceive or unwilling to commit to contraceptive methods.
- •Any comorbidities or treatment with experimental drugs that according to the investigator could bias study results or entail additional risks for the participant.
- •Participants with chronic hepatitis B and/or active hepatitis C or concurrent active or progressive liver disease.
- •Participants with history of any of the following comorbidities: stroke, heart failure, dementia, myocardial infarction and cancer or history of lactic acidosis.
- •Participants with decreased tissue perfusion or hemodynamic instability due to infection or other causes
- •Participants with active alcohol abuse: a. For men, heavy drinking is typically defined as consuming 15 drinks or more per week. b. For women, heavy drinking is typically defined as consuming 8 drinks or more per week.
- •Participants unable to swallow study medication tablets during the treatment period.
- •Participants receiving other medications that according to study drug label are contraindicated with metformin.
- •Participants with hypersensitivity or intolerance to any of the components of the study interventions as determined by the investigator.
- •Participants that are unwilling to abstain from participating in another interventional clinical trial during the study follow up.
结局指标
主要结局
EAA difference by Phenoage epigenetic clock
EAA difference by Phenoage epigenetic clock
次要结局
- 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
研究者
Jose Ramon Arribas Lopez
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
研究点 (1)
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