RECRUITING

Tfh Dysfunction in HIV and Aging

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Conditions

Human InfluenzaHIVAgingflu vaccinationhigh dose vaccinationimmune function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people to understand how aging and HIV infection affect the immune responses (body defenses against infection) to the flu vaccine.

Official Title

Tfh Dysfunction in HIV and Aging

Quick Facts

Study Start:2020-10-30
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04487041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. For HIV positive participants:
  2. * 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.
  3. * Additional criteria for HIV positive
  4. 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,
  5. 2. Cluster of differentiation 4 (CD4) count available in the prior 6 months and \>200/mm3
  6. 3. Undetectable viral load (\< 40 copies/mL). Blips of \<1000 copies/mL will be allowed.
  7. 2. For HIV negative participants:
  8. * Documented negative HIV test at the time of study entry, either by any licensed ELISA.
  9. 3. For all participants:
  10. 1. Individuals age: ≤35 years and ≥65 years.
  11. 2. No history of other immunodeficiency disorders
  12. 3. Not on steroid or other immunosuppressive/immunomodulators medications.
  13. 4. No active malignancies.
  14. 5. Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination.
  15. 6. Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons.
  16. 7. Able to provide informed consent.
  17. 1. Contraindication to receive influenza vaccination.
  18. 2. Non-adherence to ART for HIV positive
  19. 3. Unable to provide informed consent.
  20. 4. Influenza vaccination already given during the current vaccination season.
  21. 5. Known drug abuse including cocaine by history
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Suresh Pallikkuth, PhD
CONTACT
3052435315
spallikkuth@med.miami.edu

Principal Investigator

Savita Pahwa, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Savita Pahwa, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-30
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-10-30
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • Aging
  • flu vaccination
  • high dose vaccination
  • immune function

Additional Relevant MeSH Terms

  • Human Influenza