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

Primary Purpose

Obesity, HIV-1-infection

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Semaglutide Injectable Product
Standard of care
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, HIV, weight loss, GLP-1 analogue, immune activation, viral reservoir, gut microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mater Misericordiae University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Semaglutide 0.25/0.5/1 mg plus standard of care

Standard of care alone

Arm Description

Outcomes

Primary Outcome Measures

Changes in total body weight (in Kg)
Between-group differences in percent change from baseline to week 28 in total body weight

Secondary Outcome Measures

Proportion of subjects not achieving 5% weight loss from baseline to week 16
Between-group differences in number of subjects who do not achieve a 5% weight loss (in Kg) from baseline to week 16
Changes in numbers and function of immune cell subsets
Between-group differences in percent change from baseline in numbers and functions of immune cells subsets (NK cells, MAIT cells, T-cells and Monocytes) as assessed through flow cytometry in a single assay
Changes in quantified viral reservoir in peripheral blood mononuclear cells (PBMCs)
Between-group differences in percent change from baseline in HIV pro-viral DNA and cell-associated RNA (CA-RNA), measured in PBMCs (copies/mL)
Changes in gut microbiome composition in stool samples
Between-group differences in percent change from baseline in gut microbiome composition (% prevalence of different microbial species) as assessed through molecular techniques in stool samples
Changes in parameters of glucose metabolism in blood samples
Between-group differences in percent change from baseline in blood glucose levels (in mmol/L), HbA1c (in mmol/mol) and insulin levels (in pmol/L)
Changes in parameters of lipid metabolism
Between-group differences in percent change from baseline in lipid profile: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (all in mmol/L)
Proportion of subjects reporting any adverse event
Between-group differences in the number of subjects reporting any type of adverse event, including serious adverse events and suspected unexpected serious adverse reactions
Changes in bone mineral density (BMD) and total body composition
Between-group differences in percent change from baseline in lumbar spine and hip BMD and total body composition (% fat mass and lean mass) as assessed through DXA scan
Changes in liver stiffness
Between-group differences in percent change from baseline in liver stiffness (measured in kPa) as assessed thourgh liver elastography

Full Information

First Posted
November 6, 2019
Last Updated
October 23, 2023
Sponsor
University College Dublin
Collaborators
University of Copenhagen, Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04174755
Brief Title
Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
Acronym
SWIFT
Official Title
Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin
Collaborators
University of Copenhagen, Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.
Detailed Description
A randomised, controlled, parallel-group, open-label study comparing treatment with the GLP-1 analogue semaglutide in combination with lifestyle interventions to lifestyle interventions alone in obese PWH. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, HIV-1-infection
Keywords
obesity, HIV, weight loss, GLP-1 analogue, immune activation, viral reservoir, gut microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 0.25/0.5/1 mg plus standard of care
Arm Type
Experimental
Arm Title
Standard of care alone
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Semaglutide Injectable Product
Other Intervention Name(s)
Ozempic
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Other Intervention Name(s)
Diet and exercise
Intervention Description
Diet and exercise advice for 40 weeks
Primary Outcome Measure Information:
Title
Changes in total body weight (in Kg)
Description
Between-group differences in percent change from baseline to week 28 in total body weight
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects not achieving 5% weight loss from baseline to week 16
Description
Between-group differences in number of subjects who do not achieve a 5% weight loss (in Kg) from baseline to week 16
Time Frame
16 weeks
Title
Changes in numbers and function of immune cell subsets
Description
Between-group differences in percent change from baseline in numbers and functions of immune cells subsets (NK cells, MAIT cells, T-cells and Monocytes) as assessed through flow cytometry in a single assay
Time Frame
40 weeks
Title
Changes in quantified viral reservoir in peripheral blood mononuclear cells (PBMCs)
Description
Between-group differences in percent change from baseline in HIV pro-viral DNA and cell-associated RNA (CA-RNA), measured in PBMCs (copies/mL)
Time Frame
40 weeks
Title
Changes in gut microbiome composition in stool samples
Description
Between-group differences in percent change from baseline in gut microbiome composition (% prevalence of different microbial species) as assessed through molecular techniques in stool samples
Time Frame
40 weeks
Title
Changes in parameters of glucose metabolism in blood samples
Description
Between-group differences in percent change from baseline in blood glucose levels (in mmol/L), HbA1c (in mmol/mol) and insulin levels (in pmol/L)
Time Frame
40 weeks
Title
Changes in parameters of lipid metabolism
Description
Between-group differences in percent change from baseline in lipid profile: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (all in mmol/L)
Time Frame
40 weeks
Title
Proportion of subjects reporting any adverse event
Description
Between-group differences in the number of subjects reporting any type of adverse event, including serious adverse events and suspected unexpected serious adverse reactions
Time Frame
40 weeks
Title
Changes in bone mineral density (BMD) and total body composition
Description
Between-group differences in percent change from baseline in lumbar spine and hip BMD and total body composition (% fat mass and lean mass) as assessed through DXA scan
Time Frame
40 weeks
Title
Changes in liver stiffness
Description
Between-group differences in percent change from baseline in liver stiffness (measured in kPa) as assessed thourgh liver elastography
Time Frame
40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Savinelli, MD
Phone
+3532215014
Email
stefano.savinelli1@ucd.ie
Facility Information:
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
D07 R2WY
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aoife Cotter, PhD
Email
aoife.cotter@ucd.ie

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35039057
Citation
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.
Results Reference
derived

Learn more about this trial

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

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