Study on Metformin for Reversing Accelerated Aging in People Aged 50+ Living with HIV

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What is this study about?

This clinical trial is focused on studying the effects of the medication Metformin on individuals living with HIV who are 50 years or older. The study aims to explore whether Metformin can help reverse signs of accelerated aging in these individuals. Metformin is a medication commonly used to manage blood sugar levels in people with diabetes, but in this study, it is being tested for its potential anti-aging benefits. Participants in the trial will either receive Metformin or a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate the anti-aging effect of Metformin compared to a placebo. Participants will be randomly assigned to one of the two groups and will not know which treatment they are receiving. The study will last for a period of 96 weeks, during which participants will undergo regular assessments to monitor changes in their biological age. Biological age refers to how old a person seems based on various health markers, rather than their actual age in years.

Throughout the study, researchers will use different methods to measure changes in biological age, including looking at specific markers in the blood that are associated with aging. The trial will also monitor other health indicators, such as immune system function and inflammation levels, to understand the broader effects of Metformin on aging in people with HIV. The findings from this study could provide valuable insights into new ways to support healthy aging in individuals living with HIV.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, HIV status, and current health conditions.

Blood tests are performed to check HIV viral load, CD4 count, vitamin B12 levels, and other health markers.

2 randomization

Participants are randomly assigned to receive either metformin or a placebo. This process is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.

3 medication administration

Participants take the assigned medication orally in the form of a film-coated tablet.

The dosage is 850 mg of metformin hydrochloride, taken as prescribed by the study protocol.

4 ongoing monitoring

Regular follow-up visits are scheduled to monitor health status and medication effects. These visits include blood tests and assessments of biological aging markers.

Participants are monitored for changes in immune profile, inflammatory markers, and other health indicators.

5 final assessment

At the end of the study period, a final assessment is conducted to evaluate the effects of the medication on biological aging.

The primary focus is on the difference in epigenetic age acceleration, as measured by specific biological clocks.

Who Can Join the Study?

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 (a combination of medicines used to treat HIV) in the 3 months prior to study entry. A switch for tolerability, convenience, or access reasons to generic drugs or from ritonavir to cobicistat is allowed if the components of the regimen remain unchanged.
HIV viral load (the amount of HIV in the blood) must be less than 50 copies/mL at screening and in the year prior to study entry. A temporary increase (50-200 copies/mL) is allowed within 12 months prior to inclusion if it is followed by an undetectable viral load.
CD4 count (a type of white blood cell count) must be greater than 500 cells/µL at screening.
Participants must have normal vitamin B12 levels at screening.
Participants must have a normal HOMA-IR (a measure of insulin resistance) of 2.6 or less.
Body mass index (BMI) must be less than 30 kg/m².
Female participants with suspected or documented menopause. This means they are 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, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.

Who Cannot Join the Study?

Individuals with an HIV infection cannot participate. HIV is a virus that affects the immune system.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fnzjytmiu Pbzs Lq Iskyolzxosena Bwwsvvkzm Dvy Htxevute Upqffcrebzvjw Li Pfz	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	03.12.2021

Trial locations

Investigated drugs:

Metformin Hydrochloride

Metformin is a medication commonly used to treat type 2 diabetes. In this clinical trial, it is being tested for its potential to reverse accelerated biological aging in people living with HIV who are 50 years or older and have controlled viral replication. The study aims to see if Metformin can slow down or reverse the aging process by comparing it to a placebo.

Investigated diseases:

HIV infection

HIV Infection – HIV infection is caused by the human immunodeficiency virus, which attacks the body’s immune system, specifically the CD4 cells (T cells). Over time, HIV can destroy so many of these cells that the body can’t fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. In the early stages, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without intervention, HIV can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, and some may remain asymptomatic for years.

Trial ID:

2024-512287-54-00

Trial Phase:

Phase II and Phase III (Integrated)

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Study on Metformin for Reversing Accelerated Aging in People Aged 50+ Living with HIV

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