Aging Immune Function with Persistent/Chronic Conditions

As people get older, the immune system can become less effective at dealing with infectious diseases. This decreased immune function can be highly variable from person to person, and at different ages in life. Many people carry a virus (called cytomegalovirus) for their whole life – this virus causes no symptoms in most people, but may influence how their immune system works as they get older. This process of “immune aging” may happen more quickly in people with HIV infection. The overall goal of this research is to understand how the immune system ages in both healthy individuals, and those with different chronic or persistent medical conditions such as HIV. We are looking for volunteers over the age of 21 to participate in this study, including people with HIV that is well managed by medication.

Study phase: Other

Study phase (if other): Research

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Total recruitment is anticipated to be up to 3000 subjects, spread across two study Cohorts:
• HIV+ (HIV+ Cohort)
• HIV- (Healthy Aging Cohort)
Primary inclusion criteria for both cohorts of the study includes both men and women over age 21, with no history of cancer, heart attack, stroke or major organ transplant within the last 5 years.

Additional criteria for enrollment within the HIV+ Cohort includes: 1) absence of active clinical manifestations of HIV infection; 2) successful viral control with cART for >1 year (<50 copies HIV-1 RNA/ml plasma); 3) absence of immunomodulatory therapies, evidence of active acute infection (any), or malignancy.

Additional information:

What will happen if I take part in this study? The Principal Investigator or a member of his study staff will discuss the requirements for participation in this study with you. To be eligible to participate, you must be 21 years of age or older. If you agree to participate, you will be asked to come for a private interview with our study staff in which you will fill out a questionnaire about your medical history, current medications you may be taking, and physical activity level. You will be asked to walk 15 feet using any assistance devices you typically would use (if any), and we will test your “grip strength” – how tightly you can squeeze a medical device, and finally we will ask you whether you’ve recently lost weight. These measures combined with the questionnaire will allow us to determine your frailty status.

You will be asked to donate up to 100 mL of blood (~7 tablespoons); if you weigh less than 110 pounds then only 40 mL of blood (~3 tablespoons) will be drawn. Blood samples will be processed and stored at the University of Arizona Biorepository indefinitely.

You will be asked to allow us to review your medical records to access information regarding any persistent or chronic conditions you have in the past, or are currently being treated for. This information may include (but is not limited to) your medical diagnosis, age, height, weight, ethnicity, medication, treatments, HIV status and laboratory tests.

If you agree, you may be contacted again for additional blood collection(s) at later dates. You can participate just once, or repeatedly.

Total time commitment for filling out the forms and donating blood is approximately 60 minutes or less. Any future blood draws would take 30 minutes or less.

Participants will receive $20 in cash at the end of each visit. Each subject may be asked to participate up to 3 times per year ($60 max/year).

Primary disease category: Aging

This study is enrolling healthy volunteers.

Sponsor: NIH/NIA

Projected enrollment dates: November 2015 to November 2018

Official study title: Aging Immune Function with Persistent/Chronic Conditions