Clinical trial NCT06935838: Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
Official title: Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obesity and Overweight
HIV
Chronic Inflammation
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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, gender, 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 inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.


Eligibility 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

Primary outcomes:
measure: Change in Baseline Body Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Inflammatory Markers: GM-CSF
timeFrame: 12 weeks
measure: Change in cardiometabolic markers
timeFrame: 12 weeks
measure: Monocyte Subset Analysis
timeFrame: Week 12 and week 16
measure: Change in Inflammatory Markers: IFN-γ
timeFrame: 12 weeks
measure: Change in Inflammatory Markers: IL-1β
timeFrame: 12 weeks
measure: Change in Inflammatory Markers: IL-2
timeFrame: 12 weeks
measure: Change in Inflammatory Markers: IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10
timeFrame: 12 weeks
measure: Change in Inflammatory Markers: TNF-α
timeFrame: 12 weeks
measure: Change in Inflammatory Markers: NFkB
timeFrame: 12 weeks
measure: Change in Inflammatory Markers: sCD163, and sCD14
timeFrame: 12 weeks
Other outcomes:
measure: Biorepository samples for future research
timeFrame: The biorepository samples (only) will be banked for future analysis for separate research (related or unrelated to this project) for up to 7 years post-study completion.
Locations:
Study officials:
References:
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