Tfh Dysfunction in HIV and Aging

Launched by UNIVERSITY OF MIAMI · Jul 22, 2020

Keywords

ClinConnect Summary

This clinical trial, titled "Tfh Dysfunction in HIV and Aging," is aimed at understanding how HIV infection and aging affect the body’s immune response to the flu vaccine. Researchers will be looking at blood samples from both HIV-positive and HIV-negative individuals to see how well their bodies respond to the flu shot. The study is currently recruiting participants aged between 65 and 74, and it includes both men and women.

To be eligible for the study, HIV-positive participants must have a confirmed HIV infection, be on treatment for at least a year, and have specific health markers related to their HIV status. HIV-negative participants need to have a recent negative HIV test. All participants should not have any other serious health issues and must agree to receive both standard and high-dose flu vaccines over two consecutive flu seasons. If you decide to participate, you can expect regular visits and blood tests to help researchers learn more about how your immune system works with the flu vaccine. This study is important because it aims to improve the understanding of how to protect people, especially those with HIV, from the flu as they age.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. For HIV positive participants:
• • HIV infection, as documented by any licensed ELISA test kit. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection.
• • Additional criteria for HIV positive
• • 1. on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment,
• • 2. Cluster of differentiation 4 (CD4) count available in the prior 6 months and \>200/mm3
• • 3. Undetectable viral load (\< 40 copies/mL). Blips of \<1000 copies/mL will be allowed.
• 2. For HIV negative participants:
• • Documented negative HIV test at the time of study entry, either by any licensed ELISA.
• 3. For all participants:
• • 1. Individuals age: ≤35 years and ≥65 years.
• • 2. No history of other immunodeficiency disorders
• • 3. Not on steroid or other immunosuppressive/immunomodulators medications.
• • 4. No active malignancies.
• • 5. Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination.
• • 6. Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons.
• • 7. Able to provide informed consent.
• • Exclusion criteria
• • 1. Contraindication to receive influenza vaccination.
• • 2. Non-adherence to ART for HIV positive
• • 3. Unable to provide informed consent.
• • 4. Influenza vaccination already given during the current vaccination season.
• • 5. Known drug abuse including cocaine by history