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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ireland
Mater Misericordiae University Hospital
RECRUITING
Dublin
Contact Information
Primary
Stefano Savinelli, MD
stefano.savinelli1@ucd.ie
+3532215014
Time Frame
Start Date: 2022-06-22
Estimated Completion Date: 2026-01
Participants
Target number of participants: 80
Treatments
Experimental: Semaglutide 0.25/0.5/1 mg plus standard of care
Other: Standard of care alone
Related Therapeutic Areas
Sponsors
Leads: University College Dublin
Collaborators: University of Copenhagen, Rush University Medical Center

This content was sourced from clinicaltrials.gov