Status:
COMPLETED
The Visceral Adiposity Measurement and Observation Study
Lead Sponsor:
Theratechnologies
Collaborating Sponsors:
Dacima Consulting
Medpace, Inc.
Conditions:
HIV
HIV-Infections
Eligibility:
All Genders
18+ years
Brief Summary
The Visceral Adiposity Measurement and Observation Study
Detailed Description
Visceral adiposity (VA) is a form of ectopic fat deposition that correlates with cardiometabolic risk in both the general population and among people with human immunodeficiency virus (HIV) (PWH).1 Ex...
Eligibility Criteria
Inclusion
- Adult, ≥18 years
- HIV+, on continuous ART for ≥12 months
- ≥3 years since initiation of ART
- 20.0 ≤ BMI ≤ 40.0 kg/m2
Exclusion
- Detectable HIV plasma viremia 12 months prior enrollment, defined by ≥1 measurement of HIV-1 ribonucleic acid (RNA) \> 1000/mL
- Unable or unwilling to undergo any study procedures
- Known hepatic cirrhosis
- Active hepatitis C within past 12 months, defined by detectable hepatitis C RNA
- Hepatitis B positive
- Current pregnancy or breastfeeding
- History of liver transplant
- Self-reported weekly alcohol consumption meets National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for problematic drinking (binge or chronic daily intake)
- Any active malignancy, excluding non-melanoma skin cancer
- Patient has been treated with tesamorelin or human growth hormone within the last 12 months
- Patient has used insulin in the previous year
- Patient has undergone bariatric surgery in the year prior to enrollment or is currently undergoing a weight loss program
Key Trial Info
Start Date :
April 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT05383456
Start Date
April 18 2022
End Date
October 30 2023
Last Update
November 18 2023
Active Locations (8)
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1
Ruane Clinical Research
Los Angeles, California, United States, 90036
2
AIDS Healthcare Foundation
Fort Lauderdale, Florida, United States, 33308
3
AIDS Healthcare Foundation
Miami Beach, Florida, United States, 33133
4
AIDS Healthcare Foundation
Miami Beach, Florida, United States, 33140