Biomarkers for Muscle Function and Aging in Chronic HIV Infection

Study Overview
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Brief Summary
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MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy (ART) and demographically matched uninfected adults to evaluate muscle and aging.

Detailed Description
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MATCH is a non-randomized observational longitudinal study. We will recruit HIV infected adults (50 to 65 years old) and demographically matched uninfected control subjects to be followed for 4 years over the course of a 5 year study. The targeted age range of 50-65 is chosen to evaluate aging HIV infected individuals at risk for early frailty in the United States. All subjects will undergo blood draws and physical function assessment, and a subset will undergo a CT scan of muscle and will have a muscle biopsy taken. A substudy will be performed on a subgroup of HIV-infected and HIV-uninfected men from the main cohort to measure daily physical activity by using an activity tracker.

Official Title
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Biomarkers for Muscle Function and Aging in Chronic HIV Infection

Conditions
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HIV

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1: HIV positive subjects HIV positive English speaking 50-65 years old On Antiretroviral therapy and an HIV viral load below 200 copies/ml CD4 equal to or greater than 350 cells/mm3 Postmenopausal (women) Lower extremity mobility sufficient to participate in functional assessment. Group 2: HIV negative subjects Inclusion Criteria for Group 2 subjects English speaking 50-65 years old Negative for HIV (based on an HIV antibody test at Study Visit 1) Matched to Group 1 for sex (50% W, 50% M) and age (50 - 65yo) Postmenopausal (women) Lower extremity mobility sufficient to participate in functional assessment. Exclusion Criteria: Exclusion Criteria for Group 1 Subjects Acute or serious illness within 60 days prior to entry Use of pharmacologic doses of corticosteroids in the past 6 months. Use of anabolic therapy in the past 6 months. Lower extremity mobility insufficient to participate in functional assessment. Current use (last 30 days) of anticoagulants or known bleeding disorder. Exclusion Criteria for Group 2 subjects Acute or serious illness within 60 days prior to entry Use of pharmacologic doses of corticosteroids in the past 6 months Use of anabolic therapy in the past 6 months Lower extremity mobility insufficient to participate in functional assessment Current use (last 30 days) of anticoagulants or known bleeding disorder.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>HIV positive viral load < 200 copies/ml 50-65 years old CD4 > 350 cells/ml Male or Female | |
| Group 2<br>HIV negative 50-65 years old CD4 > 350 cells/ml Male or Female | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation at baseline and 3 years | Inflammation at baseline and yearly for 3 years will be assessed by measuring circulating levels of inflammatory cytokines (e.g., CRP, IL6) and soluble monocyte/macrophage biomarkers (e.g., sCD14, sC163). These multiple measurements will be aggregated to arrive at one composite inflammatory score. Outcome will be assessed in association with HIV status and physical function. | 3 years |