Print

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

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

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide
  • Drug: Tirzepatide
    Tirzepatide is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, obesity and overweight with at least one weight-related medical condition, and moderate to severe obstructive sleep apnea. An initial dose of 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.

Recruiting Locations

John A Burns School of Medicine
Honolulu, Hawaii 96813
Contact:
HICFA Clinical Coordinator
808-726-0622
tzpstudy@hawaii.edu

More Details

Status
Recruiting
Sponsor
University of Hawaii

Study Contact

HICFA Clinical Coordinator
808-726-0622
tzpstudy@hawaii.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.