An observational study in HIV and Lipodystrophy, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by University Hospitals Cleveland Medical Center · Observational
In this observational study, the investigators will examine the changes in body composition in HIV-infected subjects before and after initiation of HIV treatment, and look at the correlations with changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.
The effects of lifestyle factors on body composition changes after antiretroviral therapy (ART) are unknown, and as such, investigators will use this prospective observational cohort to study relationships between lifestyle factors, including diet, physical activity and illicit drug use, with changes in body composition after ART. In addition, the effect of the body fat changes will be correlated to changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's enrollment of 56 is below the median of 104 across 34 observational studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be primarily recruited from the practice of the investigator (the Special Immunology Unit (SIU) at University Hospitals Case Medical Center). All subjects seen at the Special Immunology Unit who meet the inclusion/exclusion criteria will be approached for study participation. Subjects who see physicians outside of the SIU may be eligible as well if they contact the study team and meet the inclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen
Diagnostic Test: Dual-energy X-ray absorptiometry
Body composition measures
Assessed using DEXA (dual energy x-ray absorptiometry) scans which will be quantifying total body fat
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Resting Energy Expenditure (REE) measures
Assessed using a BodyGem REE calculator (values in KCal)
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
endothelial function measures
Assessed using EndoPAT (values reported as a reactive hyperemia index RHI)
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
calcium score measures
Assessed using CT scans
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
central obesity
measured with waist circumference using a tape measure (in cm)
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Lipids measures
used measuring blood levels of triglycerides (mg/dL); serum high-density lipoprotein (mg/dL) ; cholesterol (mg/dL); low density lipoprotein (mg/dL)
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Fasting plasma glucose measures
fasting plasma glucose test is performed after a person has fasted for at least 8 hours (measured in mg/dL)
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Metabolic syndrome
Metabolic syndrome will be defined using the following measures: central obesity, serum triglycerides , serum high-density lipoprotein (HDL); cholesterol levels and fasting plasma glucose
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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