The Cleveland Cardiometabolic Cohort

NCT03059121 | Completed

• 1 other identifier: 06-16-19
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lipodystrophy; HIV

Keywords

HIV; Lipodystrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Resting Energy Expenditure (REE) measures

  Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year

• endothelial function measures

  Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year

• calcium score measures

  Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year

• central obesity

  Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year

• Lipids measures

  Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year

Study Arms (1)

HIV-infected ART-naïve

HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen

Diagnostic Test: Dual-energy X-ray absorptiometry

Interventions

Dual-energy X-ray absorptiometry DIAGNOSTIC_TEST

HIV-infected ART-naïve

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactation

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, plasma, feces

MeSH Terms

Conditions

Lipodystrophy

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Grace McComsey, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 23, 2017
• Study Start: September 1, 2016
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)