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

Korábbi kezelés

• 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)
• Active illicit intravenous drug use
• Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat (see prohibited/cautioned concomitant medications/therapies section)

Más betegség

• 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).
• 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
• Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide

Laborértékek

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

Egyéb

• Subjects unable to comply with the study protocol or unable to self-administer 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 is 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

• 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