The Visceral Adiposity Measurement and Observation Study

Completed

Conditions studied: HIV, HIV-Infections, HIV-1-infection, HIV I Infection, HIV Lipodystrophy, HIV Infection Primary, HIV-Associated Lipodystrophy, HIV Disease Progression, Lipohypertrophy, Liver Diseases, NAFLD, NASH, Liver Fibrosis, Hepatic Fibrosis, Waist Circumference, BMI, Ectopic Fat, Liver Fat, Hepatic Steatosis

In brief

The Visceral Adiposity Measurement and Observation Study

Key facts

Study ID

NCT05383456

Run by

Theratechnologies

People needed

196

Starts

2022-04-18

Expected to finish

2023-10-30

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult, ≥18 years
• HIV+, on continuous ART for ≥12 months
• ≥3 years since initiation of ART
• 20.0 ≤ BMI ≤ 40.0 kg/m2

You may not qualify if…

• 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

Where it is running

• Ruane Clinical Research — Los Angeles, California, United States
• AIDS Healthcare Foundation — Fort Lauderdale, Florida, United States
• AIDS Healthcare Foundation — Miami Beach, Florida, United States
• AIDS Healthcare Foundation — Miami Beach, Florida, United States
• Bliss Health — Orlando, Florida, United States
• AIDS Healthcare Foundation — New York, New York, United States
• Fight Community Health Centers — Philadelphia, Pennsylvania, United States
• Prism Health North Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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