Clinical trial NCT03059121: The Cleveland Cardiometabolic Cohort
Official title: Observational Study of Cardiometabolic Risk in HIV Infected Subjects After Initiation of Antiretroviral Therapy: the Cleveland Cardiometabolic Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Lipodystrophy
Keywords: HIV
Lipodystrophy
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Body composition measures
timeFrame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary outcomes:
measure: Resting Energy Expenditure (REE) measures
timeFrame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: endothelial function measures
timeFrame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: calcium score measures
timeFrame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: central obesity
timeFrame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Lipids measures
timeFrame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Fasting plasma glucose measures
timeFrame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Metabolic syndrome
timeFrame: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Grace McComsey, MD
role: PRINCIPAL_INVESTIGATOR
References: