HIVVAMOSNCT05383456
The Visceral Adiposity Measurement and Observation Study
An observational study of HIV and HIV-Infections, run by Theratechnologies at 8 sites in United States.
Trial summary
The Visceral Adiposity Measurement and Observation Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV-Infections, HIV-1-infection
- What is being tested?
- Diagnostic Test and HIV Anti-retroviral Background Therapy
- How many people
- 196 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Apr 2022to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The overall study population will include all participants who provide informed consent, are enrolled in the study, and complete all study procedures as required. The cardiovascular risk analysis population will not include participants who have history of CVD (myocardial infarction, cerebrovascular accident, heart failure, or atrial fibrillation). Diagnosis of normal versus excess VA using published criteria12,15,16,20 (normal visceral adiposity (NVA) versus EVA) will be based on CT evidence of VA cross-sectional area (<130cm2 or ≥130cm2, respectively).
Who may be able to join
- Adult, ≥18 years
- HIV+, on continuous ART for ≥12 months
- ≥3 years since initiation of ART
- 20.0 ≤ BMI ≤ 40.0 kg/m2
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Prism Health North Texas
Dallas, Texas, 75208
AIDS Healthcare Foundation
Fort Lauderdale, Florida, 33308
Ruane Clinical Research
Los Angeles, California, 90036
AIDS Healthcare Foundation
Miami Beach, Florida, 33133
AIDS Healthcare Foundation
Miami Beach, Florida, 33140
AIDS Healthcare Foundation
New York, New York, 10001
Bliss Health
Orlando, Florida, 32806
Fight Community Health Centers
Philadelphia, Pennsylvania, 19107
About this study
The Visceral Adiposity Measurement and Observation Study
Read the 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 Excess VA (EVA) is prevalent among PWH,2,3 and prevalence rises with age and time on antiretroviral treatment.3 Effective plasma virologic suppression is not protective against EVA and associated comorbidities, possibly due to adverse metabolic effects of certain antiretroviral agents, the low-level expression of HIV gene products within the adipose tissue, and other factos.4
Although EVA has been reported to occur in nearly half of PWH on antiretroviral therapy (ART),2,3 it may go unrecognized or be mischaracterized as generalized obesity. Whereas obesity and EVA both increase waist circumference (WC), they differ in that overweight and obese individuals accumulate fat primarily in subcutaneous depots, whereas individuals with EVA accumulate fat within the abdominal cavity. Ectopic fat accumulation (EFA) also occurs at various other depots, namely around and within various internal organs (e.g., the heart, skeletal muscle, liver, and pancreas).1,5 For purposes of the VAMOS study, EFA is defined as the amount of pericardial fat, skeletal muscle fat, and liver fat the VAMOS study subjects have. VA for the VAMOS study is held separately as it is the primary endpoint.
Because it represents a potentially modifiable cardiovascular risk factor among PWH, simple, practical surrogate markers are needed to identify patients with probable EVA. Anthropometric measurements such as WC correlate with EVA in the general population1, but their predictive value is less well defined for subgroups of PWH.
- Conditions
- HIV, HIV-Infections, HIV-1-infection, HIV I Infection, HIV Lipodystrophy, HIV Infection Primary
- Being tested
- Diagnostic Test, HIV Anti-retroviral Background Therapy
- Keywords
- HIV, HIV Infections, HIV-1-infection, HIV Lipodystrophy, HIV Infection Primary, HIV-Associated Lipodystrophy, HIV Disease Progression, Lipohypertrophy, Liver Disease, NAFLD, Liver Fat, Hepatic Steatosis, NASH, Liver Fibrosis and Hepatic Fibrosis, Ectopic Fat, Pericardial Fat, Muscle Fat/Density, Liver CAP, Liver VTCE, Waist Circumference, Anthropometric Measurements, BMI
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV-Associated Lipodystrophy Syndrome, Liver Diseases, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fatty Liver, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestDiagnostic test
Also called CT Scan, Fibroscan, Urine and Blood testing
Standard diagnostic tests.
HIV Anti-retroviral Background TherapyDrug
All participants are required be on continuous HIV Anti-retroviral Background Therapy.
No intervention on drug is part of the Study.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Waist and hip circumferences, CT Scan and FibroScan and Quality of Life questionnaire, vital signs, urine and blood testing in Adults with HIV on continuous Anti-Retroviral Therapy treatment. Receives: Diagnostic Test: Diagnostic Test; Drug: HIV Anti-retroviral Background Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical waist circumference measurement (in cm).
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Measured: Baseline
Iliac waist circumference measurement (in cm).
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Measured: Baseline
Visceral Adiposity Measurement by CT surface area (cm2).
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Measured: Baseline
Secondary outcomes (9)
Visceral Adiposity Measurement by CT surface area (cm2)
Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) and BMI (Outcome 6) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Measured: Baseline
Visceral Adiposity Measurement by CT volume (cm3).
Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) will be assessed for a relationship to Visceral Adiposity as measured by CT volume.
Measured: Baseline
Weight in kg and height in meter will be combined to report body mass index (BMI) in kg/m2.
Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) and BMI will be assessed for a predicting relationship to Visceral Adiposity as measured by CT surface area (Outcome 4), Visceral Adiposity as measured by CT volume (Outcome 5), Framingham Cardiovascular Risk strata (Outcome 9), Liver disease (Outcome 10 and 11) or Glucose homeostasis (Outcome 12).
Measured: Baseline
Health related quality of life evaluation by SF-36 questionnaire
Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.
Measured: Baseline
Health related quality of life evaluation by VAMOS disease specific questionnaire
Quality of life will be assessed for a relationship to Visceral Adiposity as measured by CT surface area.
Measured: Baseline
Framingham Cardiovascular Risk strata (low, intermediate or high)
Participant age in year, HDL-cholesterol in mmol/L, Total Cholesterol in mmol/L and systolic blood pressure in mmHg will be combined to determine the Framingham Cardiovascular Risk strata (low, intermediate or high). Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) will be assessed for a relationship to Framingham Cardiovascular Risk strata.
Measured: Baseline
Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute
To evaluate liver disease (hepatic steatosis (HS))
Measured: Baseline
Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa
To evaluate liver disease (hepatic fibrosis (HF))
Measured: Baseline
Glucose homeostasis as measured by percentage (%) of glycated form of hemoglobin in blood (HbA1c).
Two types of waist circumference (WC) measurements (Outcome 1 and Outcome 2) and BMI (Outcome 6) will be assessed for a predicting relationship to Visceral Adiposity as measured by CT surface area (Outcome 4), Visceral Adiposity as measured by CT volume (Outcome 5), Framingham Cardiovascular Risk strata (Outcome 9), Liver disease (Outcome 10 and 11) or Glucose homeostasis (Outcome 12).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start18 Apr 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theratechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dacima Consulting, Medpace, Inc., Vanderbilt University Medical Center, Echosens
- Responsible party
- Sponsor
- Investigators
- Jordan Lake, MD, Principal investigator, The University of Texas Health Science Center, HoustonJohn Koethe, MD, Principal investigator, Vanderbilt University Medical CenterJeffery Carr, DR, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383456
- Sponsor's protocol ID
- TH9507-CTR-1030
- Acronym
- VAMOS
- Status last verified
- Nov 2023
- First submitted
- 8 Apr 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neeland IJ, Ross R, Despres JP, Matsuzawa Y, Yamashita S, Shai I, Seidell J, Magni P, Santos RD, Arsenault B, Cuevas A, Hu FB, Griffin B, Zambon A, Barter P, Fruchart JC, Eckel RH; International Atherosclerosis Society; International Chair on Cardiometabolic Risk Working Group on Visceral Obesity. Visceral and ectopic fat, atherosclerosis, and cardiometabolic disease: a position statement. Lancet Diabetes Endocrinol. 2019 Sep;7(9):715-725. doi: 10.1016/S2213-8587(19)30084-1. Epub 2019 Jul 10.
PubMed 31301983Guilbaud L, Guedes JC, Gomez B, Gagne C, Thomas R, Szabo J. Lipohypertrophy, a preliminary estimate in the prevalence in an urban Canadian HIV clinic. Presented at the May 2019 CAHR Conference, Saskatoon SK. Poster 4420.
Alikhani A, Morin H, Matte S, Alikhani P, Tremblay C, Durand M. Association between lipodystrophy and length of exposure to ARTs in adult HIV-1 infected patients in Montreal. BMC Infect Dis. 2019 Sep 18;19(1):820. doi: 10.1186/s12879-019-4446-9.
PubMed 31533648Koethe JR. Adipose Tissue in HIV Infection. Compr Physiol. 2017 Sep 12;7(4):1339-1357. doi: 10.1002/cphy.c160028.
PubMed 28915327Orlando G, Guaraldi G, Zona S, Carli F, Bagni P, Menozzi M, Cocchi S, Scaglioni R, Ligabue G, Raggi P. Ectopic fat is linked to prior cardiovascular events in men with HIV. J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):494-7. doi: 10.1097/QAI.0b013e31824c8397.
PubMed 22410868Fourman LT, Kileel EM, Hubbard J, Holmes T, Anderson EJ, Looby SE, Fitch KV, Feldpausch MN, Torriani M, Lo J, Stanley TL, Grinspoon SK. Comparison of visceral fat measurement by dual-energy X-ray absorptiometry to computed tomography in HIV and non-HIV. Nutr Diabetes. 2019 Feb 25;9(1):6. doi: 10.1038/s41387-019-0073-1.
PubMed 30804324Lemoine M, Assoumou L, De Wit S, Girard PM, Valantin MA, Katlama C, Necsoi C, Campa P, Huefner AD, Schulze Zur Wiesch J, Rougier H, Bastard JP, Stocker H, Mauss S, Serfaty L, Ratziu V, Menu Y, Schlue J, Behrens G, Bedossa P, Capeau J, Ingiliz P, Costagliola D; ANRS-ECHAM Group. Diagnostic Accuracy of Noninvasive Markers of Steatosis, NASH, and Liver Fibrosis in HIV-Monoinfected Individuals at Risk of Nonalcoholic Fatty Liver Disease (NAFLD): Results From the ECHAM Study. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):e86-e94. doi: 10.1097/QAI.0000000000001936.
PubMed 30570529Lake JE, Stanley TL, Apovian CM, Bhasin S, Brown TT, Capeau J, Currier JS, Dube MP, Falutz J, Grinspoon SK, Guaraldi G, Martinez E, McComsey GA, Sattler FR, Erlandson KM. Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection. Clin Infect Dis. 2017 May 15;64(10):1422-1429. doi: 10.1093/cid/cix178.
PubMed 28329372Gabriel CL, Ye F, Fan R, Nair S, Terry JG, Carr JJ, Silver H, Baker P, Hannah L, Wanjalla C, Mashayekhi M, Bailin S, Lima M, Woodward B, Izzy M, Ferguson JF, Koethe JR. Hepatic Steatosis and Ectopic Fat Are Associated With Differences in Subcutaneous Adipose Tissue Gene Expression in People With HIV. Hepatol Commun. 2021 Feb 27;5(7):1224-1237. doi: 10.1002/hep4.1695. eCollection 2021 Jul.
PubMed 34278171Monczor AN, Li X, Palella FJ Jr, Erlandson KM, Wiley D, Kingsley LA, Post WS, Jacobson LP, Brown TT, Lake JE. Systemic Inflammation Characterizes Lack of Metabolic Health in Nonobese HIV-Infected Men. Mediators Inflamm. 2018 Sep 25;2018:5327361. doi: 10.1155/2018/5327361. eCollection 2018.
PubMed 30356397Beraldo RA, Meliscki GC, Silva BR, Navarro AM, Bollela VR, Schmidt A, Foss-Freitas MC. Comparing the Ability of Anthropometric Indicators in Identifying Metabolic Syndrome in HIV Patients. PLoS One. 2016 Feb 26;11(2):e0149905. doi: 10.1371/journal.pone.0149905. eCollection 2016.
PubMed 26919174Koethe JR, Lagathu C, Lake JE, Domingo P, Calmy A, Falutz J, Brown TT, Capeau J. HIV and antiretroviral therapy-related fat alterations. Nat Rev Dis Primers. 2020 Jun 18;6(1):48. doi: 10.1038/s41572-020-0181-1.
PubMed 32555389Pouliot MC, Despres JP, Lemieux S, Moorjani S, Bouchard C, Tremblay A, Nadeau A, Lupien PJ. Waist circumference and abdominal sagittal diameter: best simple anthropometric indexes of abdominal visceral adipose tissue accumulation and related cardiovascular risk in men and women. Am J Cardiol. 1994 Mar 1;73(7):460-8. doi: 10.1016/0002-9149(94)90676-9.
PubMed 8141087O'Neill T, Guaraldi G, Orlando G, Carli F, Garlassi E, Zona S, Despres JP, Ross R. Combined use of waist and hip circumference to identify abdominally obese HIV-infected patients at increased health risk. PLoS One. 2013 May 20;8(5):e62538. doi: 10.1371/journal.pone.0062538. Print 2013.
PubMed 23700409Hunter GR, Snyder SW, Kekes-Szabo T, Nicholson C, Berland L. Intra-abdominal adipose tissue values associated with risk of possessing elevated blood lipids and blood pressure. Obes Res. 1994 Nov;2(6):563-8. doi: 10.1002/j.1550-8528.1994.tb00106.x.
PubMed 16355516
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Visceral Adiposity Measurement and Observation Study
- ClinicalTrials.gov ID
- NCT05383456
- Acronym / sponsor ID
- VAMOS / TH9507-CTR-1030
- Conditions
- HIV, HIV-Infections, HIV-1-infection, HIV I Infection, HIV Lipodystrophy, HIV Infection Primary
- Keywords
- HIV, HIV Infections, HIV-1-infection, HIV Lipodystrophy, HIV Infection Primary, HIV-Associated Lipodystrophy, HIV Disease Progression, Lipohypertrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- TheratechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Dacima Consulting, Medpace, Inc., Vanderbilt University Medical Center, Echosens
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Excess VA (EVA) is prevalent among PWH,2,3 and prevalence rises with age and time on antiretroviral treatment.3 Effective plasma virologic suppression is not protective against EVA and associated comorbidities, possibly due to adverse metabolic effects of certain antiretroviral agents, the low-level expression of HIV gene products within the adipose tissue, and other factos.4
Although EVA has been reported to occur in nearly half of PWH on antiretroviral therapy (ART),2,3 it may go unrecognized or be mischaracterized as generalized obesity. Whereas obesity and EVA both increase waist circumference (WC), they differ in that overweight and obese individuals accumulate fat primarily in subcutaneous depots, whereas individuals with EVA accumulate fat within the abdominal cavity. Ectopic fat accumulation (EFA) also occurs at various other depots, namely around and within various internal organs (e.g., the heart, skeletal muscle, liver, and pancreas).1,5 For purposes of the VAMOS study, EFA is defined as the amount of pericardial fat, skeletal muscle fat, and liver fat the VAMOS study subjects have. VA for the VAMOS study is held separately as it is the primary endpoint.
Because it represents a potentially modifiable cardiovascular risk factor among PWH, simple, practical surrogate markers are needed to identify patients with probable EVA. Anthropometric measurements such as WC correlate with EVA in the general population1, but their predictive value is less well defined for subgroups of PWH.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Diagnostic Test: Diagnostic Test, Drug: HIV Anti-retroviral Background TherapyWaist and hip circumferences, CT Scan and FibroScan and Quality of Life questionnaire, vital signs, urine and blood testing in Adults with HIV on continuous Anti-Retroviral Therapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The overall study population will include all participants who provide informed consent, are enrolled in the study, and complete all study procedures as required. The cardiovascular risk analysis population will not include participants who have history of CVD (myocardial infarction, cerebrovascular accident, heart failure, or atrial fibrillation). Diagnosis of normal versus excess VA using published criteria12,15,16,20 (normal visceral adiposity (NVA) versus EVA) will be based on CT evidence of VA cross-sectional area (<130cm2 or ≥130cm2, respectively).
Key inclusion criteria (4 listed)
- Adult, ≥18 years
- HIV+, on continuous ART for ≥12 months
- ≥3 years since initiation of ART
- 20.0 ≤ BMI ≤ 40.0 kg/m2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic TestAlso: CT Scan, Fibroscan, Urine and Blood testingStandard diagnostic tests. | Diagnostic test | Study Participants |
| HIV Anti-retroviral Background TherapyAll participants are required be on continuous HIV Anti-retroviral Background Therapy. No intervention on drug is part of the Study. | Drug | Study Participants |
Primary outcome
Umbilical waist circumference measurement (in cm).
Time frame: Baseline
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Iliac waist circumference measurement (in cm).
Time frame: Baseline
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
Visceral Adiposity Measurement by CT surface area (cm2).
Time frame: Baseline
Two types of waist circumference (WC) measurements (umbilical and iliac) will be assessed for a predicting relationship to Excess Visceral Adiposity (EVA) as measured by CT surface area.
9 secondary outcomes
Visceral Adiposity Measurement by CT surface area (cm2)
Time frame: Baseline
Visceral Adiposity Measurement by CT volume (cm3).
Time frame: Baseline
Weight in kg and height in meter will be combined to report body mass index (BMI) in kg/m2.
Time frame: Baseline
Health related quality of life evaluation by SF-36 questionnaire
Time frame: Baseline
Health related quality of life evaluation by VAMOS disease specific questionnaire
Time frame: Baseline
Framingham Cardiovascular Risk strata (low, intermediate or high)
Time frame: Baseline
Fibroscan Controlled Attenuation Parameter (CAP) in decibels/minute
Time frame: Baseline
Fibroscan Vibration Controlled Transient Elastography (VCTE) in kPa
Time frame: Baseline
Glucose homeostasis as measured by percentage (%) of glycated form of hemoglobin in blood (HbA1c).
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 31301983Neeland IJ, Ross R, Despres JP, Matsuzawa Y, Yamashita S, Shai I, Seidell J, Magni P, Santos RD, Arsenault B, Cuevas A, Hu FB, Griffin B, Zambon A, Barter P, Fruchart JC, Eckel RH; International Atherosclerosis Society; International Chair on Cardiometabolic Risk Working Group on Visceral Obesity. Visceral and ectopic fat, atherosclerosis, and cardiometabolic disease: a position statement. Lancet Diabetes Endocrinol. 2019 Sep;7(9):715-725. doi: 10.1016/S2213-8587(19)30084-1. Epub 2019 Jul 10.
- BackgroundGuilbaud L, Guedes JC, Gomez B, Gagne C, Thomas R, Szabo J. Lipohypertrophy, a preliminary estimate in the prevalence in an urban Canadian HIV clinic. Presented at the May 2019 CAHR Conference, Saskatoon SK. Poster 4420.
- Background: PubMed 31533648Alikhani A, Morin H, Matte S, Alikhani P, Tremblay C, Durand M. Association between lipodystrophy and length of exposure to ARTs in adult HIV-1 infected patients in Montreal. BMC Infect Dis. 2019 Sep 18;19(1):820. doi: 10.1186/s12879-019-4446-9.
- Background: PubMed 28915327Koethe JR. Adipose Tissue in HIV Infection. Compr Physiol. 2017 Sep 12;7(4):1339-1357. doi: 10.1002/cphy.c160028.
- Background: PubMed 22410868Orlando G, Guaraldi G, Zona S, Carli F, Bagni P, Menozzi M, Cocchi S, Scaglioni R, Ligabue G, Raggi P. Ectopic fat is linked to prior cardiovascular events in men with HIV. J Acquir Immune Defic Syndr. 2012 Apr 15;59(5):494-7. doi: 10.1097/QAI.0b013e31824c8397.
- Background: PubMed 30804324Fourman LT, Kileel EM, Hubbard J, Holmes T, Anderson EJ, Looby SE, Fitch KV, Feldpausch MN, Torriani M, Lo J, Stanley TL, Grinspoon SK. Comparison of visceral fat measurement by dual-energy X-ray absorptiometry to computed tomography in HIV and non-HIV. Nutr Diabetes. 2019 Feb 25;9(1):6. doi: 10.1038/s41387-019-0073-1.
- Background: PubMed 30570529Lemoine M, Assoumou L, De Wit S, Girard PM, Valantin MA, Katlama C, Necsoi C, Campa P, Huefner AD, Schulze Zur Wiesch J, Rougier H, Bastard JP, Stocker H, Mauss S, Serfaty L, Ratziu V, Menu Y, Schlue J, Behrens G, Bedossa P, Capeau J, Ingiliz P, Costagliola D; ANRS-ECHAM Group. Diagnostic Accuracy of Noninvasive Markers of Steatosis, NASH, and Liver Fibrosis in HIV-Monoinfected Individuals at Risk of Nonalcoholic Fatty Liver Disease (NAFLD): Results From the ECHAM Study. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):e86-e94. doi: 10.1097/QAI.0000000000001936.
- Background: PubMed 28329372Lake JE, Stanley TL, Apovian CM, Bhasin S, Brown TT, Capeau J, Currier JS, Dube MP, Falutz J, Grinspoon SK, Guaraldi G, Martinez E, McComsey GA, Sattler FR, Erlandson KM. Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection. Clin Infect Dis. 2017 May 15;64(10):1422-1429. doi: 10.1093/cid/cix178.
- Background: PubMed 34278171Gabriel CL, Ye F, Fan R, Nair S, Terry JG, Carr JJ, Silver H, Baker P, Hannah L, Wanjalla C, Mashayekhi M, Bailin S, Lima M, Woodward B, Izzy M, Ferguson JF, Koethe JR. Hepatic Steatosis and Ectopic Fat Are Associated With Differences in Subcutaneous Adipose Tissue Gene Expression in People With HIV. Hepatol Commun. 2021 Feb 27;5(7):1224-1237. doi: 10.1002/hep4.1695. eCollection 2021 Jul.
- Background: PubMed 30356397Monczor AN, Li X, Palella FJ Jr, Erlandson KM, Wiley D, Kingsley LA, Post WS, Jacobson LP, Brown TT, Lake JE. Systemic Inflammation Characterizes Lack of Metabolic Health in Nonobese HIV-Infected Men. Mediators Inflamm. 2018 Sep 25;2018:5327361. doi: 10.1155/2018/5327361. eCollection 2018.
- Background: PubMed 26919174Beraldo RA, Meliscki GC, Silva BR, Navarro AM, Bollela VR, Schmidt A, Foss-Freitas MC. Comparing the Ability of Anthropometric Indicators in Identifying Metabolic Syndrome in HIV Patients. PLoS One. 2016 Feb 26;11(2):e0149905. doi: 10.1371/journal.pone.0149905. eCollection 2016.
- Background: PubMed 32555389Koethe JR, Lagathu C, Lake JE, Domingo P, Calmy A, Falutz J, Brown TT, Capeau J. HIV and antiretroviral therapy-related fat alterations. Nat Rev Dis Primers. 2020 Jun 18;6(1):48. doi: 10.1038/s41572-020-0181-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Lake, MD principal investigator
The University of Texas Health Science Center, Houston
John Koethe, MD principal investigator
Vanderbilt University Medical Center
Jeffery Carr, DR principal investigator
Vanderbilt University Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and HIV-Infections, run by Theratechnologies at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical waist circumference measurement (in cm). (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05383456, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.