The Cleveland Cardiometabolic Cohort

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Study of Cardiometabolic Risk in HIV Infected Subjects After Initiation of Antiretroviral Therapy: The Cleveland Cardiometabolic Cohort

Conditions
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HIV, Lipodystrophy

Intervention / Treatment
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* Diagnostic Test: Dual-energy X-ray absorptiometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test Provides written informed consent and is capable of reading and comprehending the informed consent Is not currently taking antiretroviral therapy and has never been on such treatments in the past. Exception would be for subjects who had been in the past on ≤30 days cumulative antiretrovirals, as long as these were stopped >6 months prior to study entry Is planning on starting antiretroviral therapy as part of routine clinic care Exclusion Criteria: Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected ART-naïve<br>HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen | Diagnostic Test: Dual-energy X-ray absorptiometry<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition measures | Assessed using DEXA (dual energy x-ray absorptiometry) scans which will be quantifying total body fat | Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Energy Expenditure (REE) measures | Assessed using a BodyGem REE calculator (values in KCal) | 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) | Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year | 
| calcium score measures | Assessed using CT scans | 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) | 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) | 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) | 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 | Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipodystrophy, HIV