The Cleveland Cardiometabolic Cohort

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Brief Title

The Cleveland Cardiometabolic Cohort

Official Title

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

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.
    

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 Type

Observational


Primary Outcome

Body composition measures

Secondary Outcome

 Resting Energy Expenditure (REE) measures

Condition

HIV



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

September 2016

Completion Date

August 2022

Primary Completion Date

August 2021

Eligibility Criteria

        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
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Grace McComsey, MD, 216-844-2739, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03059121

Organization ID

Pending


Responsible Party

Sponsor-Investigator

Study Sponsor

Grace McComsey


Study Sponsor

Grace McComsey, MD, Principal Investigator, University Hospitals Cleveland Medical Center


Verification Date

July 2020