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

Yale University

Status and phase: Enrolling; Phase 1

Conditions: Healthy; HIV Infections

Treatments: Drug: Active Delta-9-THC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04920539

R01DA052846 (U.S. NIH Grant/Contract)

2000030067

Details and patient eligibility

About

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.

Full 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 alterations differ between HIV-infected and HIV-uninfected host genomes. To test these hypotheses, the investigators propose defining the epigenomic and transcriptomic alterations at single cell resolution in peripheral blood mononuclear cells by administering THC to humans with and without HIV infection. The THC-associated epigenomic/transcriptomic alterations will be linked to genomic variants to understand the causal effects of THC response in immune cells.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Active Delta-9-THC

Experimental group

Description:

Active Delta-9-THC (0.03 mg/kg) administered intravenously.

Treatment:

Drug: Active Delta-9-THC