Actively Recruiting
Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
Led by University of Hawaii · Updated on 2025-11-28
12
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.
CONDITIONS
Official Title
Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Documented HIV-1 infection diagnosed at least 1 year prior to study entry
- HIV-1 RNA viral load less than 200 copies/mL for at least 6 months
- Receiving a stable antiretroviral therapy regimen for at least 1 year prior to study entry
- Overweight (BMI 27 kg/m2 or higher) with at least one weight-related condition such as dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep apnea, or obese (BMI 30 kg/m2 or higher)
You will not qualify if you...
- Not explicitly provided in the source
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
John A Burns School of Medicine
Honolulu, Hawaii, United States, 96813
Actively Recruiting
Research Team
H
HICFA Clinical Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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