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OpenTrials
Active, Not Recruiting

NCT Number: NCT04304768

Opioid, HIV and Immune System

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

  • 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:

  • 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 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.

Treatment and study plan

Fluzone Quadrivalent

Biological

0.5 ml prefilled syringe administrated intramuscularly

Other names: Influenza vaccination

Primary outcomes

  1. 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.

Secondary outcomes

  1. Immune activation levels

    Time frame: Baseline

    Activation of T and B cells from peripheral blood mononuclear cells assessed via flow cytometry.

  2. 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.

  3. Circulating T follicular helper cell function

    Time frame: Week 4

    T follicular helper cell function measured from peripheral blood mononuclear cells via flow cytometry.

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Immune Dysfunction in HIV+ Opioid Users

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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