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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 120 minutes post-dronabinol and 360 minutes post-dronabinol, up 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq

Secondary outcome measures

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

Side effects data

From 2019 Phase 4 trial • 46 Patients • NCT03008005

13%

Nausea and Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Dronabinol Cap 5 Milligrams (MG)

Placebo Oral Capsule

Dronabinol Cap 10 Milligrams (MG)

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

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,401 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,571 Total Patients Enrolled

Ke Xu, MD, PhDPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the FDA sanctioning cannabis therapy for those living with HIV/AIDS?

"The safety of Cannabis use amongst PWH has been assessed as a 1 due to the limited clinical data that exists regarding its efficacy and safety, which is typical for Phase 1 trials."

Answered by AI

Are there any remaining available slots in this research project?

"Per the clinicaltrials.gov portal, this medical trial is not presently in search of participants. Initially posted on October 1st 2023 and updated as recently as September 5th 2023, it does not appear to be looking for candidates at this time; however there are 230 other studies recruiting patients currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Dronabinol-HIV

2023. "Oral Dronabinol-HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034314.

All > Cannabis