Phase 2 HIV and AIDS Trial, Recruiting NCT05514899 Sponsor: University of California, San Diego Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT05514899
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged between 21 and 70 years old
  • People who are able to understand and agree to take part in a series of brain and medical assessments
  • People who have used cannabis at least once in the past 5 years without serious negative reactions (such as psychosis or fainting)
  • People who have used cannabis very little or not at all in the past 2 weeks — meaning either no use, or no more than one time in that period
  • People who are willing to avoid cannabis, CBD, THC, and synthetic cannabinoids outside of the study for the full 6-week study period
  • People who are able to attend all required study visits
  • People living with HIV may be considered if they meet all of the following additional conditions: their HIV virus levels are undetectable and they have been on a stable HIV treatment (ART) regimen for at least 6 months with no more than one past treatment change due to the virus becoming resistant; their HIV is classified as Stage 1 or 2; their immune cell count (CD4) is at or above 350 cells per microlitre; and they have not had significant difficulty sticking to their HIV medication regimen

Who may not be able to join:

  • People who have had a substance use disorder (other than cannabis) in the past 30 days
  • People with significant memory or thinking problems, such as dementia or Alzheimer's disease
  • People who are pregnant, breastfeeding, or unwilling to use reliable contraception during the trial (for people who could become pregnant, or whose partner could become pregnant)
  • People with moderate or severe liver or kidney problems, including certain abnormal liver test results (confirm with trial site)
  • People with significant heart health concerns, including a resting heart rate below 50 or above 110 beats per minute, poorly controlled blood pressure, or a history of heart attack, heart failure, or irregular heart rhythms
  • People with a chronic lung condition that requires supplemental oxygen
  • People with a history of liver or bile duct illness, or certain abnormal liver test results detected at screening (confirm with trial site)
  • People who require insulin to manage diabetes
  • People with a known allergy to the study drugs or their ingredients, including sesame
  • People taking medications that are known to interact with the study drugs (confirm with trial site)
  • People taking medications that cause sedation
  • People who weigh less than 60 kg at the time of screening
  • People with an active and uncontrolled psychiatric condition involving psychotic features, severe depression, or suicidal thoughts or behaviour — including a history of suicide attempts, or a score of 29 or higher on a standard depression questionnaire (BDI-II)
  • People with a neurological condition that could affect the study results, such as uncontrolled seizures in the past 3 months, multiple sclerosis, Parkinson's disease, Alzheimer's disease, or a recent stroke or brain bleed with lasting neurological effects

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ronald J Ellis, MD, PhD, UC San Diego

Phone: 619-543-5000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 September 2023
Est. completion
31 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

PC1; PC1

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov