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Search / Trial NCT04920539

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

Launched by YALE UNIVERSITY · Jun 3, 2021

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how THC, the active ingredient in cannabis, may affect the immune system in people with HIV compared to those without HIV. Researchers want to understand if THC changes certain genes and the way immune cells produce substances called cytokines, which help regulate the immune response. This study is looking for participants who are either HIV-positive or HIV-negative and are in good health otherwise.

To be eligible, HIV-positive participants must be consistently taking their medication and have a clean urine test for drugs, while HIV-negative participants also need a negative urine test and good overall health. Participants can expect to undergo various health evaluations, including interviews and tests, to ensure they meet the study's health criteria. The trial is currently recruiting individuals aged between 18 and 74 years, and it’s important to note that those with serious medical conditions or who are pregnant cannot take part.

Gender

ALL

Eligibility 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)

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

West Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Deepak C D'Souza, MD

Principal Investigator

Yale University Professor of Psychiatry

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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