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Opioid, HIV and Immune System

StatusActive, Not Recruiting
PhasePhase 4
Started2020-11-18
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Study Status, References v12
Publicationsdetails revised at 3 of 3 entries
2026-03-19
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations, References v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-03-31→2027-01-31
Completion date2026-12-31→2027-12-31
Study sitesdetails revised at 1 of 1 site
2025-12-02
Study Status, Study Design, Contacts/Locations v10
Enrollment target300→400
Study sitescontacts updated at 1 of 1 site
2025-05-28
Study Status v9
Primary completion date2025-05-31→2026-03-31
Completion date2025-05-31→2026-12-31
2024-09-06
3 amendments v6-v8
3 re-verifications since 2022-10-17, no change to tracked fields
Show 5 earlier versions
2021-11-10
Study Status, Study Design, Outcome Measures, Eligibility v5
Enrollment target260→300
Eligibility criteria-42 characters
[...] RT for at least 1 year with plasma pending viral load (VL) <50200 copies/mL. Occasional viral blips up to 1000 copies/ml also [...] the prior 6 months and >200/mm3 Undetectable viral load (< 40200 copies/mL) For HIV negative participants: 1) Documented neg [...] ination already given during the current vaccination season. Polydrug abuse including cocaine by history
2021-01-13
Study Status, Study Design, Eligibility v4
Enrollment target350→260
Eligibility criteria-1 characters
[...] in the past 6 months. For all participants: Individuals age >18-60 yrs . No history of other immunodeficiency disorders N [...]
2020-12-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-11-01→confirmed 2020-11-18
Study sitesdetails revised at 1 of 1 site
2020-08-14
Study Status v2
Start date2020-09-01→2020-11-01
2020-05-20
Study Status v1
Start date2020-06-01→2020-09-01
2020-03-10
Original filing
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.
Trial Details
NCT Number NCT04304768
Lead Sponsor University of Miami
Conditions Immune Defect
Enrollment 400 participants
Start Date 2020-11-18
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-27