Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
Purpose
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
- Obesity and Overweight
- HIV
- Chronic Inflammation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Age ≥ 18 years
HIV-1 infection (well controlled)
- Documented HIV-1 infection ≥ 1 year prior to study entry (ELISA confirmed by Western
blot or HIV-1 RNA) AND
- HIV-1 RNA <200 copies/mL for ≥ 6 months
Stable ART
· Receiving a stable antiretroviral regimen for at least 1 year prior to study entry
Overweight
- BMI ≥27 kg/m2 plus at least one weight-related condition (defined as a medical
history of dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep
apnea) OR Obese
- BMI ≥ 30 kg/m2
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tirzepatide |
|
Recruiting Locations
Honolulu, Hawaii 96813
More Details
- Status
- Recruiting
- Sponsor
- University of Hawaii