Biomarkers for Muscle Function and Aging in Chronic HIV Infection (MATCH)

Mass General Brigham

Status: Unknown

Conditions: HIV

Study type: Observational

Funder types: Other

Identifiers

NCT03011957

2014P002489

Details and patient eligibility

About

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

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

160 participants in 2 patient groups

Group 1

Description:

HIV positive viral load \< 200 copies/ml 50-65 years old CD4 \> 350 cells/ml Male or Female

Group 2

Description:

HIV negative 50-65 years old CD4 \> 350 cells/ml Male or Female