Biomarkers for Muscle Function and Aging in Chronic HIV Infection

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03011957

Acronym

MATCH

Enrollment

160

Registered

2017-01-06

Start date

2015-02-28

Completion date

2020-02-29

Last updated

2018-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results