NCT04304768Active, not recruitingPhase 4
Opioid, HIV and Immune System
Immune Dysfunction in HIV+ Opioid Users
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people opioid and non opioid users to understand how opioid 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
- 9 Mar 2020
- Start date
- 18 Nov 2020
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- University of Miami
- Diseases
- HIV
- NCT number
- NCT04304768
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 18 Nov 2020 to the primary completion date, 31 Jan 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.
Other illness
- Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
- Non-adherence to ART for HIV+
- Other comorbid conditions such as diabetes mellitus type 2 (DMT2)
Other
- Unable to provide informed consent.
- Influenza vaccination already given during the current vaccination season.
Who the study is looking for
- For Opioid (OP) users/non-users:
- OP users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days
- Opioid never-users in the past year
- Additional criteria for OP users:
- OP use for 90 days pre-flu vaccination
- Continued OP use for 4 weeks post flu vaccination
- For HIV positive participants:
- 1\) HIV infection, as documented by any licensed ELISA kit and confirmed by Western blot at any time prior to study entry. 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 participants:
- On ART for at least 1 year with plasma pending viral load (VL) \<200 copies/mL. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment
- CD4 count available in the prior 6 months and \>200/mm3
- Undetectable viral load (\< 200 copies/mL)
- For HIV negative participants:
- 1\) Documented negative HIV test, either by any licensed ELISA or rapid tests within the past 6 months.
- For all participants:
- Individuals age 18-60 yrs .
- No history of other immunodeficiency disorders
- Not on steroid or other immunosuppressive/immunomodulators medications.
- No active malignancies.
- No contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
- Agreeable to receive the influenza vaccination.
- Agreeable to participate in study for a complete course of study full visits.
- Able to provide informed consent.
Age in the registry: 18 years to 60 years · 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 |
This page is information, not medical advice. Discuss any trial with your doctor.