Immune Dysfunction in HIV+ Opioid Users

Who is this study for? Patients with Immune Defect
What treatments are being studied? Fluzone Quadrivalent
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

⁃ 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Savita Pahwa, MD
spahwa@med.miami.edu
3052437732
Backup
Suresh Pallikkuth, PhD
SPallikkuth@med.miami.edu
3052435315
Time Frame
Start Date: 2020-11-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 300
Treatments
Experimental: HIV positive opioid users
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
Experimental: HIV positive non-opioid users
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
Experimental: HIV negative opioid users
Participants will receive flu vaccination as part of the study
Experimental: HIV negative non-opioid users
Participants will receive flu vaccination as part of the study
Related Therapeutic Areas
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov

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