RECRUITING

The Cleveland Cardiometabolic Cohort

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-09

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03059121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* Pregnancy or lactation

Inclusion Criteria

Exclusion 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

* Pregnancy or lactation

Contacts and Locations

Study Contact

Danielle Labbato, BSN

CONTACT

216-844-2739

danielle.labbato@uhhospitals.org

Grace McComsey, MD

CONTACT

mccomsey.grace@clevelandactu.org

Principal Investigator

Grace McComsey, MD

PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Grace McComsey

Grace McComsey, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-09

Study Completion Date2024-12

Study Record Updates

Study Start Date2016-09

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

HIV
Lipodystrophy

Additional Relevant MeSH Terms

HIV
Lipodystrophy