NCT04487041Active, not recruitingPhase 4
Tfh Dysfunction in HIV and Aging
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 22 Jul 2020
- Start date
- 30 Oct 2020
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- University of Miami
- Diseases
- HIV
- NCT number
- NCT04487041
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 30 Oct 2020 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known drug abuse including cocaine by history
Other illness
- Non-adherence to ART for HIV positive
Other
- Contraindication to receive influenza vaccination.
- Unable to provide informed consent.
- Influenza vaccination already given during the current vaccination season.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
Related publications
- High-dose influenza vaccine augments serological and cellular immunity of older people with HIV.JCI Insight · 2026 · PMID 41785036
This page is information, not medical advice. Discuss any trial with your doctor.