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Dronabinol for HIV/AIDS

Phase 1
Recruiting
Led By Ke Xu, MD, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV-positive on antiretroviral therapy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 120 minutes post-dronabinol and 360 minutes post-dronabinol, up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial seeks to understand how cannabis affects people living with HIV and its effects on the immune system. Results could inform policy and new treatments.

Who is the study for?
This trial is for adults with HIV/AIDS who currently use or have used cannabis, are on antiretroviral therapy, and have a low viral load. They must be in good health overall and women able to bear children should agree to use birth control during the study.
What is being tested?
The study tests Dronabinol Capsules to understand their effects on immune function and inflammation in people with HIV who consume cannabis. It will explore if these effects depend on one's HIV status, potentially guiding future treatments.
What are the potential side effects?
While not explicitly listed here, Dronabinol may cause dizziness, mood changes, headaches, confusion or memory impairment; however individual experiences can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am HIV-positive and on antiretroviral therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 120 minutes post-dronabinol and 360 minutes post-dronabinol, up 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 120 minutes post-dronabinol and 360 minutes post-dronabinol, up 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq
Secondary study objectives
Change in Dronabinol-induced chromatin structure profile in blood samples using single cell (sc)ATAC-seq
Identification of Dronabinol related cellular gene networks in blood samples

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: People without HIV (PWoH) with Cannabis useExperimental Treatment1 Intervention
PWoH with Cannabis use
Group II: People with HIV (PWH) with Cannabis useExperimental Treatment1 Intervention
PWH with cannabis use

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,498 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,589 Previous Clinical Trials
3,328,357 Total Patients Enrolled
Ke Xu, MD, PhDPrincipal InvestigatorYale University
~67 spots leftby Oct 2025