Using Semaglutide to Help People with HIV Lose Weight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of semaglutide, a GLP-1 analogue, in promoting weight loss among obese individuals living with HIV. Participants will be randomly assigned to receive either semaglutide alongside lifestyle interventions or lifestyle interventions alone. The study aims to assess not only weight loss but also the impact of semaglutide on immune function, glucose and lipid metabolism, and gut microbiome in this population. The trial will include adults over 18 years old who are stable on antiretroviral therapy and meet specific BMI criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be over 18 years old
* Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISA assay
* Be stable on ART with a viral load suppressed \<40 copies/mL for a minimum of 2 years
* Have a CD4 count ≥200 cells/mm3 for a minimum of 1 year
* Have a BMI ≥30kg/m2 or have a BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus
* Understand the study procedures, be able to comply with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial

Exclusion Criteria:

* Subjects unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide
* History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma
* History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine).
* Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin)
* History of severe renal impairment, as defined by a baseline creatinine clearance \<30ml/min
* Individuals with a diagnosis of HIV-associated lipoatrophy/lipodystrophy, based on physician's assessment
* Individuals with severe hepatic impairment (Child Pugh score \>9)
* Subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection
* Any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study
* History of cancer (apart from treated Kaposi's Sarcoma) and/or receiving chemotherapy or radiotherapy
* Active illicit intravenous drug use
* Subjects concurrently enrolled in another clinical trial of an investigational medicinal product.
* The investigator may decide that a subject cannot proceed in the study if there is any relevant other abnormal results in the screening assessments
* Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide
* Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat (see prohibited/cautioned concomitant medications/therapies section)
* For female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study

Where it's running

• Mater Misericordiae University Hospital
  Dublin, Dublin, Ireland Recruiting

Study contacts

• Study coordinator: Stefano Savinelli, MD
• Email: stefano.savinelli1@ucd.ie
• Phone: +3532215014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.