Examining how THC affects immune responses in HIV-infected and healthy individuals
In Vivo Study of THC-induced Immune-genome Changes At Single Cell Solution in HIV-infected Humans
This study is testing how THC affects the immune system in both people with HIV and those who are healthy to see if there are any differences in how it works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT04920539 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of THC on the immune genome at a single-cell level in both HIV-infected and uninfected individuals. The researchers aim to understand how THC alters cytokine production through epigenetic mechanisms and whether these changes differ between the two groups. By administering THC and analyzing peripheral blood mononuclear cells, the study seeks to link epigenomic and transcriptomic changes to genomic variants, providing insights into THC's impact on immune responses.
Who should consider this trial
Good fit: Ideal candidates include HIV-positive individuals with good medication adherence and HIV-negative individuals in good health.
Not a fit: Patients with major medical conditions or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for managing immune responses in HIV-infected patients.
How similar studies have performed: While studies on THC's effects on the immune system exist, this specific approach examining single-cell alterations in the context of HIV is relatively novel.
Eligibility criteria
Show full inclusion / 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)
Where this trial is running
West Haven, Connecticut
- VA Connecticut Healthcare System — West Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Deepak C D'Souza, MD — Yale University Professor of Psychiatry
- Study coordinator: Lynn X Wang, MS
- Email: lynda.wang@yale.edu
- Phone: 203-948-1435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.