2024-513168-24-00招募中2 期
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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Change from baseline in total body weight at week 28.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Subjects unable to comply with the study protocol or unable to selfadminister subcutaneous semaglutide
- •History of obesity induced by other endocrine disorders: Cushing’s syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma
- •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.
- •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
- •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
- •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
- •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
- •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 are 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 Section 5.2.2 Prohibited/Cautioned Concomitant Medications/Therapies)
- •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.
结局指标
主要结局
Change from baseline in total body weight at week 28.
Change from baseline in total body weight at week 28.
次要结局
- Change from baseline in total and subcutaneous fat, as measured by DXA at week 28.
- Changes from baseline to week 28 in markers of B-cell function, T-cell function, innate immunity, inflammation, gut microbiome composition, adipose tissue function, cholesterol and glucose metabolism and HIV RNA and HIV viral reservoir.
- The proportion of subjects in both arms not achieving ≥ 5% weight loss from baseline at week 16.
- Proportion with reported AE/AR, SAE/SAR
- Change in health-related quality of life (QOL) at week 28.
- Change in PR interval (sec) on ECG from baseline to week 4 stratified by class of antiretrovirals
研究者
Paddy Mallon
Scientific
University College Dublin
研究点 (5)
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