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Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV

RECRUITINGPhase 2Sponsored by University of Hawaii
Actively Recruiting
PhasePhase 2
SponsorUniversity of Hawaii
Started2025-11-12
Est. completion2026-07-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Chronic InflammationHIVObesity and OverweightWeight Loss

Locations1 site

John A Burns School of Medicine
Honolulu, Hawaii, 96813
HICFA Clinical Coordinator808-726-0622tzpstudy@hawaii.edu

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