The Cleveland Cardiometabolic Cohort



Status:Recruiting
Conditions:HIV / AIDS, Endocrine, Gastrointestinal
Therapuetic Areas:Endocrinology, Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:5/6/2018
Start Date:September 2016
End Date:August 2022
Contact:Danielle Labbato, BSN
Email:danielle.labbato@uhhospitals.org
Phone:216-844-2739

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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.

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.

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
We found this trial at
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Cleveland, Ohio 44194
Phone: 216-844-2739
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