Opioid, HIV and Immune System

March 24, 2026 updated by: Savita Pahwa, University of Miami

Immune Dysfunction in HIV+ Opioid Users

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIV positive opioid users
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
Biological: Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
Other Names:
  • Influenza vaccination
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
Biological: Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
Other Names:
  • Influenza vaccination
Experimental: HIV negative opioid users
Participants will receive flu vaccination as part of the study
Biological: Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
Other Names:
  • Influenza vaccination
Experimental: HIV negative non-opioid users
Participants will receive flu vaccination as part of the study
Biological: Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
Other Names:
  • Influenza vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the antibody response
Time Frame: Baseline, 4 weeks, 6 months
Antibody response as measured by the serum vaccine antigen specific hemagglutination inhibition antibody levels.
Baseline, 4 weeks, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune activation levels
Time Frame: Baseline
Activation of T and B cells from peripheral blood mononuclear cells assessed via flow cytometry.
Baseline
Inflammation biomarker levels
Time Frame: Baseline
Plasma levels of Interleukin (IL)-6, IL-8, IL-12, IL-17, IL-22, Tumor necrosis factor (TNF) and monocyte activation markers soluble CD14 and soluble CD163 will be assessed via Magpix. All the biomarkers will be measured in nanograms/milliliter.
Baseline
Circulating T follicular helper cell function
Time Frame: Week 4
T follicular helper cell function measured from peripheral blood mononuclear cells via flow cytometry.
Week 4
Circulating T follicular helper cell frequency
Time Frame: Week 4
T follicular helper cell frequency measured from peripheral blood mononuclear cells via flow cytometry.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Savita Pahwa, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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