Status:
RECRUITING
Opioid, HIV and Immune System
Lead Sponsor:
University of Miami
Conditions:
Immune Defect
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04304768
Start Date
November 18 2020
End Date
December 31 2026
Last Update
December 4 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136