HIVNCT03059121
The Cleveland Cardiometabolic Cohort
An observational study of HIV and Lipodystrophy, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV, Lipodystrophy
- What is being tested?
- Dual-energy X-ray absorptiometry
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 19 May 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Observational Study of Cardiometabolic Risk in HIV Infected Subjects After Initiation of Antiretroviral Therapy: The Cleveland Cardiometabolic Cohort
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.
Read the detailed description
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.
- Conditions
- HIV, Lipodystrophy
- Being tested
- Dual-energy X-ray absorptiometry
- Keywords
- HIV, Lipodystrophy
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy X-ray absorptiometryDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected ART-naïve | HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen Receives: Diagnostic Test: Dual-energy X-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition measures
Assessed using DEXA (dual energy x-ray absorptiometry) scans which will be quantifying total body fat
Measured: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary outcomes (7)
Resting Energy Expenditure (REE) measures
Assessed using a BodyGem REE calculator (values in KCal)
Measured: 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)
Measured: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
calcium score measures
Assessed using CT scans
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startSep 2016
- Primary completion19 May 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace McComsey, University Hospitals Cleveland Medical Center
- Investigators
- Grace McComsey, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059121
- Sponsor's protocol ID
- 06-16-19
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2017
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Cardiometabolic Risk in HIV Infected Subjects After Initiation of Antiretroviral Therapy: The Cleveland Cardiometabolic Cohort
- ClinicalTrials.gov ID
- NCT03059121
- Acronym / sponsor ID
- 06-16-19
- Conditions
- HIV, Lipodystrophy
- Keywords
- HIV, Lipodystrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 23 Feb 2017 (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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infected ART-naïve | – | Diagnostic Test: Dual-energy X-ray absorptiometryHIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy or lactation
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 |
|---|---|---|
| Dual-energy X-ray absorptiometry | Diagnostic test | HIV-infected ART-naïve |
Primary outcome
Body composition measures
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Assessed using DEXA (dual energy x-ray absorptiometry) scans which will be quantifying total body fat
7 secondary outcomes
Resting Energy Expenditure (REE) measures
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
endothelial function measures
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
calcium score measures
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
central obesity
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Lipids measures
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Fasting plasma glucose measures
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Metabolic syndrome
Time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
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 28 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Grace McComsey, MD principal investigator
University Hospitals Cleveland Medical Center
1 site 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 Lipodystrophy, run by University Hospitals Cleveland Medical Center at 1 site 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 1 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Body composition measures (time frame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.