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Study of Exercise and Drug Interventions for Inflammation in Smokers

This study is looking at whether a combination of exercise, a supplement called spermidine, and either lamivudine or rapamycin can help with inflammation. Lamivudine is typically used for HIV and Hepatitis B, while rapamycin is an FDA-approved drug that affects the immune system. You might be able to join if you are between 65 and 80 years old, are a current or former smoker, and have a body mass index (BMI) between 25 and 32. The study aims to see how safe these interventions are and if participants can complete the drug part of the study for 180 days. The current recruitment status is unclear.

Study design
This study is an interventional study with a planned enrollment of 22 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive an exercise regimen, take an oral dosage of spermidine for 180 days, and either lamivudine or rapamycin for 180 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 180 days, indicating a follow-up period of at least 180 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07058974

A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation

Active, Not Recruiting
PHASE1Ages 60–85InterventionalPrevention
Icahn School of Medicine at Mount Sinai
~20 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:lamivudinerapamycinExercise RegimenSpermidine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0
Measured over at 180 days
+1 more outcome measured

Conditions

Smokers
Former Smokers

Explore related trials

Tobacco Use

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Thomas Marron, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients 60-85 years old
Current or former smokers
BMI 25-35
No cancer requiring active therapy within the last 2 years
No autoimmune disease requiring disease modifying agents
No patients with EGFR \<30 or ESRD
No class 3 or 4 heart failure

Exclusion

Patients may not have cancer requiring active therapy within the last 2 years
Patients may not have autoimmune disease requiring disease modifying agents
Patients may not be receiving immune modifying biologic therapies
Patients may not have chronic kidney disease stage 3/4 or end stage renal disease
Patients may not have a known history of metabolic dysfunction-associated steatohepatitis
Patients may not have a known chronic viral infection such as HIV or active Hepatitis B or C, or a known history of genital HSV. Patients who have spontaneously or through treatment cleared hepatitis B or C are candidates for the trial. If Hepatitis B core ab is positive must document a negative PCR.
Patients may not have class 3 or 4 heart failure, or have experienced a myocardial infarction or cerebrovascular event in the past 6 months
Patients may not have uncontrolled diabetes mellitus
Patients may not have a history of clinically significant interstitial lung disease (ILD).
Patients may not have clinically significant active wound healing due to recent injury or surgery
Patients may not have signs or symptoms of clinically significant acute infectious illness on screening laboratory testing or physical examination.
Patients may not have evidence of active or latent tuberculosis
Patients may not have nephrotic range proteinuria on screening labs
Patients may not have received a live virus within one month of study initiation.
Patients cannot have uncontrolled hypertension (persistent systolic \>160; diastolic \>100)
Patients with an inherited primary immunodeficiency
Patients may not have a history of, or current evidence of, clinically significant chronic liver disease
Patients may not be receiving any chronic immunosuppressive therapy.
Patients may not be receiving medications that could increase rapamycin blood concentrations, such as strong inhibitors and inducers of CYP3A4 and/or P-gp (ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin; rifampin or rifabutin), bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, protease inhibitors, metoclopramide, nicardipine, troleandomycin, verapamil. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
Patients may not be receiving medications that could decrease rapamycin blood concentrations, such as: carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's Wort. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
Patients may not be receiving medications known to cause angioedema with concomitant use of rapamycin, such as angiotensin-converting enzyme (ACE) inhibitors. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.

What this trial measures

  • Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0at 180 days

    Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0. Toxicity will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Any patient experiencing a Grade 3 or 4 adverse event must hold drug until toxicity returns to grade 0-1. The treating investigator may hold study drug for any duration if the patient is deemed to be experiencing a Grade 1-2 adverse event related to study drug.

  • Number of participants with ability to complete >80% of specified pharmacological interventionat 180 days

    Feasibility of the trial is determined by participant documentation of taking at least 80% of the provided study drug on a regular basis, ability to complete \>80% of specified pharmacological intervention.