Status:
RECRUITING
In Vivo Study of THC-induced Immune-genome Changes at Single Cell Solution in HIV-infected Humans
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
In this study, the investigators hypothesize that THC alters the immunogenome in a cell type-specific fashion and alters cytokine production via epigenetic regulatory mechanisms and that these alterat...
Detailed Description
In this study, the investigators hypothesize that THC alters the immunogenome in a cell type-specific fashion and alters cytokine production via epigenetic regulatory mechanisms and that these alterat...
Eligibility Criteria
Inclusion
- Inclusion Criteria (HIV-infected group):
- HIV-positive
- Good medication adherence
- Negative urine toxicology for drugs of abuse (including cannabis)
- Good mental and physical health (other than HIV) as determined by history, psychiatric interview, collateral information, physical and laboratory examinations, ECG, and vital signs.
- Inclusion Criteria (HIV-uninfected group):
- HIV-negative
- Negative urine toxicology for drugs of abuse (including cannabis)
- Good mental and physical health as determined by history, psychiatric interview, collateral information, physical and laboratory examinations, ECG, and vital signs.
- Exclusion Criteria (common to both groups):
- Major medical conditions, e.g., myocardial infarction, hypertension, etc.
- Positive pregnancy test and lactation;
- Weight greater than 166 kg (365 lbs)
Exclusion
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04920539
Start Date
February 8 2022
End Date
September 30 2026
Last Update
November 5 2025
Active Locations (1)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516