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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

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 to 11 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,189 Previous Clinical Trials

1,587,701 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