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Opioid, HIV and Immune System

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Immune DefectFlu vaccine response and HIV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Immune Dysfunction in HIV+ Opioid Users

Quick Facts

Study Start:2020-11-18
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04304768

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. OP users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days
  2. 2. Opioid never-users in the past year
  3. 1. OP use for 90 days pre-flu vaccination
  4. 2. Continued OP use for 4 weeks post flu vaccination
  5. 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
  6. 2. CD4 count available in the prior 6 months and \>200/mm3
  7. 3. Undetectable viral load (\< 200 copies/mL)
  8. 1. Individuals age 18-60 yrs .
  9. 2. No history of other immunodeficiency disorders
  10. 3. Not on steroid or other immunosuppressive/immunomodulators medications.
  11. 4. No active malignancies.
  12. 5. No contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
  13. 6. Agreeable to receive the influenza vaccination.
  14. 7. Agreeable to participate in study for a complete course of study full visits.
  15. 8. Able to provide informed consent.
  1. 1. Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
  2. 2. Non-adherence to ART for HIV+
  3. 3. Unable to provide informed consent.
  4. 4. Other comorbid conditions such as diabetes mellitus type 2 (DMT2)
  5. 5. Influenza vaccination already given during the current vaccination season.

Contacts and Locations

Study Contact

Savita Pahwa, MD
CONTACT
3052437732
spahwa@med.miami.edu
Suresh Pallikkuth, PhD
CONTACT
3052435315
SPallikkuth@med.miami.edu

Principal Investigator

Savita Pahwa, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Savita Pahwa, MD, PRINCIPAL_INVESTIGATOR, University of Miami

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 Registration Dates

Study Start Date2020-11-18
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2020-11-18
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • Flu vaccine response and HIV

Additional Relevant MeSH Terms

  • Immune Defect