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

Mass General Brigham logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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