Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT04487041

Tfh Dysfunction in HIV and Aging

Led by University of Miami · Updated on 2025-05-30

400

Participants Needed

1

Research Sites

321 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tfh Dysfunction in HIV and Aging

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • HIV positive participants must have documented HIV infection by licensed ELISA test or be on ART due to prior HIV diagnosis
  • HIV positive participants must be on ART for at least 1 year, allowing occasional viral blips up to 1000 copies/ml
  • HIV positive participants must have a CD4 count greater than 200/mm3 within the prior 6 months
  • HIV positive participants must have an undetectable viral load below 40 copies/mL, with blips under 1000 copies/mL allowed
  • HIV negative participants must have a documented negative HIV test by licensed ELISA at study entry
  • Participants must be aged 35 years or older
  • No history of other immunodeficiency disorders
  • Not taking steroids or other immunosuppressive or immunomodulatory medications
  • No active malignancies
  • Agreeable to receive both standard and high dose influenza vaccinations
  • Agreeable to complete full study visits over two consecutive flu seasons
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to receiving influenza vaccination
  • Non-adherence to ART for HIV positive participants
  • Unable to provide informed consent
  • Already received influenza vaccination during the current vaccination season
  • Known history of drug abuse including cocaine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

S

Suresh Pallikkuth, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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