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Cannabis for HIV/AIDS Treatment Effects

Phase 2
Recruiting
Led By Scott Letendre, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older;
Capacity to provide informed consent;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 to 11 days
Awards & highlights

Study Summary

This trial will study the effects of cannabis use on drugs taken to treat HIV, as well as on mood and cognition.

Who is the study for?
This trial is for adults over 18 with HIV/AIDS who are on a stable ART regimen and have used cannabis in the past two years without severe reactions. Participants must be willing to avoid cannabis, grapefruit juice, driving or operating heavy machinery as required by the study phases.Check my eligibility
What is being tested?
The study examines how cannabis affects antiretroviral therapy (ART) drug levels, mood, and cognitive function. It has two parts: an observational phase assessing chronic users of cannabis and a controlled phase where THC/CBD Cannabis or placebo is given to evaluate acute effects on ART.See study design
What are the potential side effects?
Potential side effects may include changes in mood or thinking due to THC/CBD Cannabis use. The exact side effects will be studied but can relate to known issues like disorientation or paranoia from previous cannabis use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am able to understand and agree to the study's procedures and risks.
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I have been on a stable HIV treatment for over a month and my viral load is low.
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I am currently taking a medication called an integrase inhibitor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 to 11 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 11 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1a i. Antiretroviral therapy (ART) drug concentration in blood
1a ii. Cerebrospinal fluid (CSF)/plasma ratio of ART drug concentrations
1a iii. Change in ART drug concentrations in blood
+18 more
Secondary outcome measures
1b v. Comparison between the effects of THC and CBD on ART pharmacokinetics.
1b vi. Comparison between the effects of THC and CBD on the CSF/plasma ratio of ART drug concentrations.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: THC CannabisActive Control1 Intervention
11.86% THC/ 1.12% CBD
Group II: CBD CannabisActive Control1 Intervention
0.35% THC/ 11.27% CBD
Group III: PlaceboPlacebo Group1 Intervention
≤ 0.01% THC/ ≤ 0.01% CBD

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,520,884 Total Patients Enrolled
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
589 Total Patients Enrolled
Scott Letendre, MDPrincipal Investigator - UCSD
Regents Of The University Of California -Ucsd Physician Assoc, Regents of the University of California - UCSD Medical Group, UC San Diego Health System-Hillcrest, UCSD Medical Center-Hillcrest
Georgetown University School Of Medicine (Medical School)
Duke University Medical Center (Residency)
2 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

THC Cannabis Clinical Trial Eligibility Overview. Trial Name: NCT04800159 — Phase 2
HIV/AIDS Research Study Groups: THC Cannabis, Placebo, CBD Cannabis
HIV/AIDS Clinical Trial 2023: THC Cannabis Highlights & Side Effects. Trial Name: NCT04800159 — Phase 2
THC Cannabis 2023 Treatment Timeline for Medical Study. Trial Name: NCT04800159 — Phase 2

Frequently Asked Questions

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

Has there been any other research conducted in relation to the usage of THC from Cannabis?

"Currently, 31 clinical trials are underway that involve THC Cannabis. 3 of these studies have surpassed the Phase 2 stage and entered into testing efficiency in a more advanced phase. While Hartford is where most of the research takes place, there are 46 other sites actively conducting related experiments."

Answered by AI

Is enrollment for this research study open at the present time?

"According to the info available on clinicaltrials.gov, this medical research is presently enrolling patients. It was initially published on February 19th 2021 and most recently updated August 23rd 2022."

Answered by AI

Are there any known perils associated with the consumption of THC Cannabis?

"As this is still a Phase 2 trial, there exists some evidence that THC Cannabis can be safely administered; hence we gave it an assessment of two. As yet, no clinical data supports its efficacy."

Answered by AI

What is the current enrollment of participants in this clinical study?

"Yes, the information present on clinicaltrials.gov alludes to this trial actively seeking subjects for their research. This medical investigation was initially posted on February 19th 2021 and recently updated as of August 23rd 2022; 40 people are being admitted at a single site."

Answered by AI

Has a comparable investigation been undertaken previously?

"The first study on THC Cannabis was conducted in 2015 by Jazz Pharmaceuticals, with 200 participants. Afterward, the drug received Phase 2 & 3 approval and is now currently being tested through 31 trials located across 32 cities and 5 nations."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Ucsd Hnrp-Cmcr
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Cannabis Effects on Antiretroviral Therapy Pharmacokinetics and Neurotoxicity
Scott Letendre 2021. "Cannabis Effects on Antiretroviral Therapy Pharmacokinetics and Neurotoxicity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04800159.
All > Toxicity
~8 spots leftby Jan 2025
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