Phase 2 HIV and AIDS Trial, Recruiting NCT07040592 Sponsor: Yale University Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT07040592
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 who have been diagnosed with HIV
  • People who receive their care at the Atlanta VA Healthcare System
  • People who are 18 years of age or older
  • People who meet the criteria for mild, moderate, or severe alcohol use disorder, as measured by two standard assessment tools (the DSM-5 Alcohol Symptom Checklist and the AUDIT-C screen)
  • People who have a blood test result showing significant recent alcohol use (a PEth level above 20ng/ml)
  • People who are currently prescribed 5 or more medications
  • People who have a cell phone or a reliable contact number
  • People who are able to provide written informed consent to participate

Who may not be able to join:

  • People who are already actively taking part in a formal alcohol treatment program, including those already taking medications specifically for alcohol use disorder, at the time of enrollment
  • People who are pregnant, nursing, or trying to become pregnant (confirmed by self-report or a lab test)
  • People who have a life-threatening or unstable medical, surgical, or mental health condition that would prevent safe participation — including those who have had thoughts of harming themselves or others in the past 12 months and are not currently receiving treatment for this
  • People who have moderate to severe opioid use disorder that is not currently being treated
  • People who live outside of the state of Georgia (confirm with trial site)
  • People who are unable to read or understand English
  • People who have had a serious allergic reaction or significant adverse reaction to the study medication in the past
  • People who are currently taking certain diabetes medications that may interact with the study medication
  • People with a Body Mass Index (a measure of body weight relative to height) below 23
  • People who have been diagnosed with type 1 diabetes
  • People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma), a hormone gland condition called Multiple Endocrine Neoplasia syndrome type 2, a condition that severely slows digestion (including gastroparesis), a history of pancreatitis (unless the cause is known and no longer poses a risk), or severe gallbladder disease
  • People with certain serious eye conditions related to diabetes, including advanced diabetic retinopathy, significant swelling in the central part of the eye (macular edema), or a related eye condition called cystoid macular edema
  • People who are already prescribed the medication being studied at the time of recruitment

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 7 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: E. Jennifer Edelman, MD, MHS, Yale University

Phone: 203-737-7115

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
Sponsor
Registry
ClinicalTrials.gov
Start date
15 January 2026
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of participants who complete enrollment and duration of sessions; Number of sessions completed; Adherence to Medication; Safety of study assessed by adverse event reporting

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: 7 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