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

January 16, 2018 updated by: Monty Montano, Brigham and Women's Hospital
MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy (ART) and demographically matched uninfected adults to evaluate muscle and aging.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group 1: 66 HIV+ (both men and women), 50 through 65 years of age, on effective antiretroviral therapy (ART).

Group 2: 94 HIV- (both men and women), 50 through 65 years of age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
HIV positive viral load < 200 copies/ml 50-65 years old CD4 > 350 cells/ml Male or Female
Group 2
HIV negative 50-65 years old CD4 > 350 cells/ml Male or Female

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation at baseline and 3 years
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Monty A Montano, PhD, Brigham and Womens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P002489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only aggregate data will be made available through publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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