Clinical trial NCT04304768: Opioid, HIV and Immune System
Official title: Immune Dysfunction in HIV+ Opioid Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Immune Defect
Keywords: Flu vaccine response and HIV
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: 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.

Primary outcomes:
measure: Change in the antibody response
timeFrame: Baseline, 4 weeks, 6 months
Secondary outcomes:
measure: Immune activation levels
timeFrame: Baseline
measure: Inflammation biomarker levels
timeFrame: Baseline
measure: Circulating T follicular helper cell function
timeFrame: Week 4
measure: Circulating T follicular helper cell frequency
timeFrame: Week 4
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Savita Pahwa, MD
role: PRINCIPAL_INVESTIGATOR
References: