HIV and AIDS Trial, Recruiting NCT07226128 Sponsor: Indiana University Condition: HIV and AIDS
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HIV and AIDS Trial, Recruiting

NCT07226128
Recruiting Not Applicable

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 a confirmed HIV-1 diagnosis, documented in their medical records through an approved HIV test, antigen test, or viral load measurement
  • People who are 18 years of age or older
  • People who have been taking the same HIV treatment (antiretroviral therapy) continuously for at least 180 days before the screening visit
  • People whose depression meets all of the following conditions: a score of 10 or higher on a standard depression questionnaire (PHQ-9); having depressed mood or loss of interest plus at least one other depressive symptom in the past two weeks; experiencing difficulties in daily social or work life due to these symptoms; no clear evidence that a substance, medication, or other medical condition is directly causing the depression; and no history of bipolar disorder or psychosis
  • People whose blood sugar control level (HbA1c) is below 6.5% at the screening visit
  • People whose HIV viral load is below 75 copies/mL at the screening visit (meaning HIV is well controlled)

Who may not be able to join:

  • People who are unable to complete a written informed consent process
  • People who are unable to read and understand English on a computer screen
  • People who have been diagnosed with diabetes, or who have ever had a recorded HbA1c blood sugar level of 6.5% or higher
  • People with a diagnosed history of bipolar disorder or a psychotic disorder, including schizophrenia
  • People who are incarcerated at the time of any study visit
  • People who are assessed as actively suicidal at the time of the entry visit, as determined by their HIV doctor or social worker using a specific suicidality assessment process (confirm with trial site for details)
  • People who have a diagnosed condition (other than HIV) known to cause widespread inflammation in the body, such as lupus or inflammatory bowel disease (confirm with trial site if uncertain whether a specific condition applies)
  • People with kidney failure who require dialysis or have had a kidney transplant
  • People who have a known or suspected cancer that has required whole-body (systemic) treatment within the 180 days before the entry visit
  • People who have received treatment for a serious medical illness within 14 days before the entry visit
  • People who are currently pregnant or breastfeeding
  • People who are currently receiving experimental drugs, chemotherapy, systemic immune-suppressing medications, systemic steroid medications, or anabolic steroids at the time of the entry visit
  • People whose active drug use or dependence, in the opinion of the study team, would make it difficult to follow study requirements

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Samir K Gupta, MD, Indiana University

Phone: 1-317-278-0255

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
10 April 2026
Est. completion
30 June 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from baseline in HOMA-IR at 24 weeks

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