Biomarkers for Muscle Function and Aging in Chronic HIV Infection

• Conditions: HIV

• Registration Number: NCT03011957
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18
• Primary Completion: 2019-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammation at baseline and 3 years	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States