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NCT04304768 | RECRUITING | Immune Defect

Opioid, HIV and Immune System
Sponsor:

University of Miami

Information provided by (Responsible Party):

Savita Pahwa

Brief Summary:

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 or disease

Immune Defect

Intervention/treatment

Fluzone Quadrivalent

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Immune Dysfunction in HIV+ Opioid Users
Actual Study Start Date : 2020-11-18
Estimated Primary Completion Date : 2025-05-31
Estimated Study Completion Date : 2025-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • For Opioid (OP) users/non-users
    • 1. OP users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days
    • 2. Opioid never-users in the past year
    • Additional criteria for OP users
      • 1. OP use for 90 days pre-flu vaccination
      • 2. 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
          • 1. 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
          • 2. CD4 count available in the prior 6 months and \>200/mm3
          • 3. 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
              • 1. Individuals age 18-60 yrs .
              • 2. No history of other immunodeficiency disorders
              • 3. Not on steroid or other immunosuppressive/immunomodulators medications.
              • 4. No active malignancies.
              • 5. No contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
              • 6. Agreeable to receive the influenza vaccination.
              • 7. Agreeable to participate in study for a complete course of study full visits.
              • 8. Able to provide informed consent.
              Exclusion Criteria
              • 1. Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
              • 2. Non-adherence to ART for HIV+
              • 3. Unable to provide informed consent.
              • 4. Other comorbid conditions such as diabetes mellitus type 2 (DMT2)
              • 5. Influenza vaccination already given during the current vaccination season.
Opioid, HIV and Immune System

Location Details

NCT04304768

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Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136