A randomised, controlled, parallel group, open-label trial evaluating the impact of treatment with the GLP-1 analogue semaglutide on weight loss in people living with HIV and obesity (SWIFT Study)

Prior treatment

• Active illicit intravenous drug use
• Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat (see Section 5.2.2 Prohibited/Cautioned Concomitant Medications/Therapies)
• Subjects with a diagnosis of diabetes mellitus who either have proliferative retinopathy or maculopathy requiring treatment or have not undergone retinal screening within the previous 12 months.
• 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)

Other illness

• Personal or family history of medullary thyroid carcinoma (MTC) or in individuals with Multiple Endocrine Neoplasia (MEN)
• 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
• Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide
• Ongoing or history of severe gastroparesis
• History of obesity induced by other endocrine disorders: Cushing’s syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma
• History of lipoatrophy or lipodystrophy, as per 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) coinfection

Lab values

• History of severe renal impairment, as defined by a baseline creatinine clearance <30ml/min

Other

• Subjects unable to comply with the study protocol or unable to selfadminister subcutaneous semaglutide
• 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 are any relevant other abnormal results in the screening assessments
• 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.
• History hypothyroidism that has recently been poorly-controlled, defined as a TSH <0.5 mU/L or >10 mU/L within the last 12 months

• Be over 18 years old
• Be HIV-1 antibody positive as determined by a positive 3rd or 4th generation Ag/Ab ELISA assay
• Be on stable ART for at least 2 years, with the last two viral loads <40 copies/mL or equivalent, based on local testing protocols
• 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 (see Appendix G – Diagnostic Criteria)
• 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