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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)
EU CTIS ID: 2024-513168-24-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Subjects unable to comply with the study protocol or unable to selfadminister subcutaneous semaglutide
- 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
See the full eligibility criteria
- 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
- Subjects unable to comply with the study protocol or unable to selfadminister subcutaneous semaglutide
- 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.
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.