Active — Not RecruitingPhase 4

Opioid, HIV and Immune System

United States400 participantsStarted 2020-11-18

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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
✓. OP use for 90 days pre-flu vaccination
✓. Continued OP use for 4 weeks post flu vaccination
✓. 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)
✓. Individuals age 18-60 yrs .

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.

What they're measuring

Change in the antibody response

Timeframe: Baseline, 4 weeks, 6 months

Trial details

NCT IDNCT04304768

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

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