Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV

Inclusion Criteria:

• Be over 18 years old

• Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISAassay

• 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 2diabetes mellitus

• Understand the study procedures, be able to comply with the study procedures, andvoluntarily 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-administersubcutaneous semaglutide

• History of obesity induced by other endocrine disorders: hypothyroidism, Cushing'ssyndrome, primary and secondary hypogonadism, hypothalamic disorders, polycysticovary syndrome, insulinoma

• History of obesity induced by use of anti-psychotic medications known to beassociated with weight gain (i.e. olanzapine, clozapine).

• Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide orexenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3months (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 onphysician's assessment

• Individuals with severe hepatic impairment (Child Pugh score >9)

• Subjects with active hepatitis B infection (defined as hepatitis B sAg positive) orhepatitis C (defined as hepatitis C Ab and RNA positive) co-infection

• Any active illness (including AIDS-defining illness) which in the opinion of theinvestigator precludes participation in the study

• History of cancer (apart from treated Kaposi's Sarcoma) and/or receivingchemotherapy or radiotherapy

• Active illicit intravenous drug use

• Subjects concurrently enrolled in another clinical trial of an investigationalmedicinal product.

• The investigator may decide that a subject cannot proceed in the study if there isany relevant other abnormal results in the screening assessments

• Subjects with any known or suspected hypersensitivity to semaglutide or any of theexcipients 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 futurepregnancies or unwilling to take measures to avoid pregnancy for the duration of thestudy