Immune Dysfunction in HIV+ Opioid Users

  • End date
    May 31, 2025
  • participants needed
  • sponsor
    University of Miami
Updated on 21 October 2022
Accepts healthy volunteers


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.

Condition Immune Defect
Treatment Fluzone Quadrivalent
Clinical Study IdentifierNCT04304768
SponsorUniversity of Miami
Last Modified on21 October 2022


Yes No Not Sure

Inclusion Criteria

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
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
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

Exclusion Criteria

Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine)
Non-adherence to ART for HIV+
Unable to provide informed consent
Other comorbid conditions such as diabetes mellitus type 2 (DMT2)
Influenza vaccination already given during the current vaccination season
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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