Rapamycin and Infection-related Illness

There is limited clinical research to support the efficacy of rapamycin toward preventing the incidence and reducing the severity of infectious disease or infection-related illness in humans. The off-label use of rapamycin to prevent infection may be implemented safely in healthy individuals with well-controlled medical conditions and/or prescribed medications compatible with its established indications detailed in the FDA-approved prescription label/medical guide. Pregnant women, organ transplant recipients (especially lung and liver), and patients with cancer, serious wounds or infections, allergies to rapamycin and its derivatives, hyperlipidemia and recent vaccinations are particularly compromised. Short term dosing regimens are generally well-tolerated with mild to moderate adverse events and no severe adverse events in patients qualifying and receiving treatment. Long term use should be evaluated further, and the use of rapamycin derivatives in healthy patients as an infection preventive therapy warrants further investigation.

This study proposes to observe the following parameters prior to, and at 3 and 6 months after the initiation of the observational study:

• Safety [no. and level of adverse events, MSQ, SPB and DPB, blood platelet counts, lipid profiles, ECG, cognitive function, depression symptoms, systemic inflammation, urinalysis (only in female participants of child-bearing age for pregnancy test)]
• Incidence of infectious disease or infection-related illness
• Severity of infectious disease or infection-related illness
• Incidence of infection-related hospitalizations
• Quality of Life (RAND SF-36 Health Survey)
• Global Health Questionnaire (PROMIS-GHF V1.2)
• Patient Self-Report Questionnaire of symptoms, incidence and severity of infectious disease or infection-related illness and hospitalizations one year prior and 3 and 6 months following the initiation of the observational study.

Patients at the Hoskinson Health and Wellness Clinic qualifying for treatment with (Rapamune (Sirolimus) receive a prescription from their physician during clinic visits as part of their standard health care. Patients do not have to participate in this study to receive medical treatment with Rapamune (Sirolimus) for their condition.

Measurement of infection related illness parameters [Complete Blood Count (CBC), White Blood Cell Count (WBC), Neutrophils, Lymphocytes, Eosinophils, Basophils, Monocytes, C-Reactive Protein (CRP), Procalcitonin (PCT), Erythrocyte Sedimentation Rate (ESR), Absolute Neutrophil Count (ANC)], fasting total cholesterol (TC), High (HDL) and Low (LDL) lipoproteins and triglycerides, inflammatory biomarkers (CRP, Tumor Necrosis Factor (TNFα), requires a blood draw, which is associated with some discomfort and minor risks such as a slight bruising of the arm. A registered nurse will be available to assist with all blood draws/testing. Study participants will be advised of the known risks and consequences associated with the testing and also of the reasonably known risks and consequences of not undergoing testing.

The Quality of Life (RAND SF-36 Health Survey), Global Health Questionnaire (PROMIS-GHF V1.2) Patient self-report questionnaire, systolic blood pressure (SPB) and diastolic blood pressure (DPB), electrocardiogram (ECG), medical symptoms questionnaire (MSQ), Cognitive function by Montreal Cognitive Assessment [MoCA (Jak-Bondi Criteria)] and Advanced Digital Cognitive Assessment (BrainCheck)], Depression by the Center for Epidemiologic Studies Depression Scale (CES-D Scale) are non-invasive and no adverse reactions or side effects are expected.

As with any routine clinical care paradigm, other primary potential risks include a breach of confidentiality and loss of privacy from unauthorized disclosure of the study participants' personal health information. Such events could conceivably lead to economic loss for patients through discriminatory practices. However, this study presents minimal risks to the study participants whose data are being analyzed because rigorous precautions will be employed to protect privacy, confidentiality and security of personal health information. These precautions are outlined in the Data and Safety Monitoring Plan (DSMP).

Study participants will be advised of the known risks and consequences associated with the testing and also of the reasonably known risks and consequences of not undergoing testing. A physician will be present at each testing visit to assess any potential side effects or complications. A registered nurse will be in attendance to assist with all testing. The investigators are experienced in providing a safe environment where study participants feel comfortable, especially with tests that require them to remain motionless for extended periods of fame.