Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
NCT ID: NCT04174755
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2022-06-22
2026-01-31
Brief Summary
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Detailed Description
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The study will enroll HIV-1 infected patients ≥ 18 years with BMI ≥30kg/m2 or BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus.
Primary objective: To assess the efficacy of semaglutide as an adjunct to diet and exercise in achieving greater weight loss in obese PWH as compared to diet and exercise alone.
Secondary objectives:
* To explore the effect of semaglutide on markers of immune function and HIV viral reservoirs in obese PWH.
* To explore the effect of semaglutide on markers of glucose and lipid metabolism in obese PWH.
* To explore the effect of semaglutide on markers of inflammation and gut microbial translocation in obese PWH.
* To assess the safety of semaglutide in obese PWH on stable ART.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Semaglutide 0.25/0.5/1 mg plus standard of care
Semaglutide Injectable Product
Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.
Standard of care
Diet and exercise advice for 40 weeks
Standard of care alone
Standard of care
Diet and exercise advice for 40 weeks
Interventions
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Semaglutide Injectable Product
Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.
Standard of care
Diet and exercise advice for 40 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Rush University Medical Center
OTHER
University College Dublin
OTHER
Responsible Party
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Patrick Mallon
Professor of Microbial Diseases
Locations
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Mater Misericordiae University Hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Aoife Cotter, PhD
Role: primary
References
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O'Sullivan L, Savinelli S, O'Hare S, Holden S, McHugh C, Mallon P, Doran P. An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT). Trials. 2022 Jan 17;23(1):50. doi: 10.1186/s13063-021-05979-y.
Other Identifiers
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SWIFT Study
Identifier Type: -
Identifier Source: org_study_id