Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV -1 Infection
- Obesity
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04174755
- Collaborators
- University of Copenhagen
- Rush University Medical Center
- Investigators
- Not Provided
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