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New treatment option for HIV
Official title Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
ClinicalTrials.gov ID: NCT05514899
What this study is testing
What is THC?
THC is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv.
Also referred to as Delta-9 tetrahydrocannabinol, Tetrahydrocannabinol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Aged 21 to 70 years old
- Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.
- Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)
- No or low cannabis use in the past 2 weeks, defined as no cannabis exposure or use or use limited to only once in the past 2 weeks.
- Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention
You likely can't join if
- Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;
- Significant cognitive impairment such as Dementia, including Alzheimer's disease
- Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial; refusal to maintain highly effective contraceptive methods (e.g...
- Evidence of moderately or worse compromised liver or kidney function, including moderate (Child-Hugh B) or severe (Child-Hugh C) hepatic impairment...
- Evidence of significant cardiovascular risk, resting heart rate \ 110 beats per minute, uncontrolled hypertension (systolic blood pressure \ 140...
- Evidence of chronic pulmonary disease requiring supplemental oxygen;
See the full eligibility criteria
- Aged 21 to 70 years old
- Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.
- Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)
- No or low cannabis use in the past 2 weeks, defined as no cannabis exposure or use or use limited to only once in the past 2 weeks.
- Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention
- Individuals with HIV must meet the following criteria
- Virally suppressed on stable ART for at least 6 months and have no more than 1 prior event of virologic failure (i.e., required change in ARTs due to virologic failure)
- Stage 1 or 2 infection
- Have a "normal" CD4 count defined as ≥350 cells/microliter
- No significant history of ART regimen adherence challenges
- Ability to adhere to the study visit schedule.
- Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;
- Significant cognitive impairment such as Dementia, including Alzheimer's disease
- Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial; refusal to maintain highly effective contraceptive methods (e.g., implants, injectables, combined oral contraceptives, some intrauterine...
- Evidence of moderately or worse compromised liver or kidney function, including moderate (Child-Hugh B) or severe (Child-Hugh C) hepatic impairment and AST and ALT above ULN and total bilirubin above ULN;
- Evidence of significant cardiovascular risk, resting heart rate \ 110 beats per minute, uncontrolled hypertension (systolic blood pressure \ 140 mmHg; diastolic blood pressure \ 90 mmHg), history of myocardial...
- Evidence of chronic pulmonary disease requiring supplemental oxygen;
- Active, recent, or remote medical history of hepatobiliary-related illness, including elevated transaminase levels above 3 times the upper limit of normal accompanied by elevations in total bilirubin above 2 times the...
- Insulin dependent diabetics
- Allergy to the study drugs or any of their constituents including sesame
- Use of medications with absolute contraindicated or potential significant interactions
- Use of sedating medications
- Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol;
- Active, uncontrolled psychiatric disorder with psychotic features, severe depression, or suicidality; Participants will be excluded if they have had a history of suicide attempt, recent suicidal ideation or behavior as...
- Neurologic disorder that could compromise interpretation of study findings, including uncontrolled seizure disorder (active seizures within the past 3 months), multiple sclerosis, Parkinson's disease, Alzheimer's...
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.