Phase 3 Obesity Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who have a confirmed HIV diagnosis and have never been on HIV treatment (ART) before
• People who have signed a form agreeing to take part in the trial
• People whose HIV viral load (the amount of HIV in the blood) is at or above 1,000 copies/mL
• People who have no history of HIV prevention medication (PrEP or PEP) not working for them
• People with a body mass index (a measure of body weight relative to height) of 25 or above, and a body fat percentage above 20%
• People who are on a stable treatment for high cholesterol or lipid-related conditions, if that applies to them
• People who have no planned changes to medications that could affect body weight
• People who are willing to follow the HIV treatment plan assigned in the trial
• People who have recent test results available for HIV viral load and immune cell count (CD4+)
• People whose kidneys are functioning at an adequate level, as measured by a specific calculation called GFR (≥60 mL/min) (confirm with trial site)
• People whose liver enzyme levels (ALT and AST) are below 90 IU/L, indicating acceptable liver function
• People who are willing to report any changes to their diet or physical activity during the trial

Who may not be able to join:

• People with diabetes that is not well controlled
• People who have changed their insulin or blood sugar medications within the past 3 months
• People with an active cancer diagnosis
• People who have had weight-loss (bariatric) surgery in the past
• People who have known allergies to the medications used in the trial
• People who also have a Hepatitis B or Hepatitis C infection
• People whose kidney function falls below the required level (GFR under 60 mL/min)
• People whose other medications may interact with the HIV treatment used in the trial
• People who have used appetite-suppressing medications in the past 60 days
• People who were hospitalised for a serious illness in the past 30 days
• People with an unstable thyroid condition that is not well managed
• People who lose their social security coverage during the trial
• People who develop a newly discovered allergy to the trial medications
• People who withdraw their consent to participate
• People who acquire a Hepatitis B or C infection during the course of the trial
• People who are on psychiatric or thyroid medications without having been on a stable dose for at least 12 weeks
• People who start or stop medications that affect body weight after enrolling in the trial
• People who undergo unplanned weight-loss (bariatric) surgery after joining the trial

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