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)

Trial details

Who runs it

University College Dublin

Trial code

EU 2024-513168-24-00

Record updated

2026. szeptember 21.

Original description

To assess the efficacy of GLP-1 analogue therapy (subcutaneous semaglutide) as an adjunct to diet and exercise in achieving greater weight loss in people living with HIV and obesity (PLWHO) as compared to diet and exercise alone.Read full original descriptionShow less

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)

To assess the efficacy of GLP-1 analogue therapy (subcutaneous semaglutide) as an adjunct to diet and exercise in achieving greater weight loss in people living with HIV and obesity (PLWHO) as compared to diet and exercise alone.

Inclusion: 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.

Exclusion: 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); 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; History of severe renal impairment, as defined by a baseline creatinine clearance <30ml/min; 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.

EU CTIS 2024-513168-24-00