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

Launched by UNIVERSITY COLLEGE DUBLIN · Nov 20, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how effective the medication semaglutide is for helping people with HIV who are also struggling with obesity lose weight. Researchers want to see if semaglutide can help these individuals lose more weight compared to just following a diet and exercise plan. They are also interested in understanding how semaglutide might affect the immune system and other health markers related to metabolism and gut health.

To participate in this study, individuals must be over 18 years old and be living with HIV with a well-controlled viral load. They should also have a body mass index (BMI) that classifies them as obese. Participants will need to be stable on their HIV treatment for at least two years. Throughout the trial, participants will receive guidance and support while taking semaglutide, and they will be monitored for any side effects. This study is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• 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