CompletedNot Applicable

The Visceral Adiposity Measurement and Observation Study

United States196 participantsStarted 2022-04-18

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Umbilical waist circumference measurement (in cm).

Timeframe: Baseline

Iliac waist circumference measurement (in cm).

Timeframe: Baseline

Visceral Adiposity Measurement by CT surface area (cm2).

Timeframe: Baseline

Trial details

NCT IDNCT05383456

SponsorTheratechnologies

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-30

View on ClinicalTrials.gov More HIV trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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)