The Cleveland Cardiometabolic Cohort

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03059121
• Other study ID #: 06-16-19
• Status: Recruiting
• Start date: September 2016
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Danielle Labbato, BSN
• Phone: 216-844-2739
• Email: danielle.labbato[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Lipodystrophy

Intervention

Diagnostic Test:
• Dual-energy X-ray absorptiometry

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Grace McComsey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	calcium score measures	Assessed using CT scans	Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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