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Incretin Microdosing for Cardiometabolic Health in People With HIV
Sponsor: The University of Texas Health Science Center, Houston
Summary
The objectives of this study are as follows: Primary Objective * To determine the rate of weight regain in people living with human immunodeficiency virus (HIV) (PWH) receiving semaglutide microdosing vs. no additional drug following induction therapy. Secondary Objectives * To evaluate the tolerability of semaglutide microdosing in adults with HIV. * To evaluate changes in weight, waist circumference (WC) and body mass index (BMI) over 12 weeks (W) of semaglutide weight loss induction and 48 W of semaglutide microdosing therapy.
Official title: Incretin Microdosing for Cardiometabolic Health in People With HIV: The REINFORCE Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-02-12
Completion Date
2029-06-30
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly
Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive microdosing with semaglutide at 0.5 mg subcutaneously every week during weeks 13-60.
Dose escalation to 2 mg semaglutide weekly then no semaglutide
Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive no semaglutide during weeks 13-60.
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States