Status:
RECRUITING
Tfh Dysfunction in HIV and Aging
Lead Sponsor:
University of Miami
Conditions:
Human Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 inf...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment,
- Cluster of differentiation 4 (CD4) count available in the prior 6 months and \>200/mm3
- Undetectable viral load (\< 40 copies/mL). Blips of \<1000 copies/mL will be allowed.
- For HIV negative participants:
- Documented negative HIV test at the time of study entry, either by any licensed ELISA.
- For all participants:
- Individuals age: ≤35 years and ≥65 years.
- No history of other immunodeficiency disorders
- Not on steroid or other immunosuppressive/immunomodulators medications.
- No active malignancies.
- Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination.
- Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons.
- Able to provide informed consent.
- Exclusion criteria
- Contraindication to receive influenza vaccination.
- Non-adherence to ART for HIV positive
- Unable to provide informed consent.
- Influenza vaccination already given during the current vaccination season.
- Known drug abuse including cocaine by history
Exclusion
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04487041
Start Date
October 30 2020
End Date
December 30 2026
Last Update
May 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami
Miami, Florida, United States, 33136