In Vivo Study of THC-induced Immune-genome Changes at Single Cell Solution in HIV-infected Humans

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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 alterations differ between HIV-infected and HIV-uninfected host genomes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Dronabinol

Criteria

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)