Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
Brigham and Women's Hospital


Information provided by (Responsible Party)
Monty Montano, Brigham and Women's Hospital

ClinicalTrials.gov Identifier
NCT03011957

First received: December 12, 2016
Last updated: January 16, 2018
Last Verified: January 2018
History of Changes
Purpose

Purpose

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

Condition
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers for Muscle Function and Aging in Chronic HIV Infection

Further study details as provided by Monty Montano, Brigham and Women's Hospital:

Primary Outcome Measures

  • 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.

Biospecimen Retention: Samples With DNA
Blood, muscle biopsy

Enrollment: 160
Study Start Date: February 2015
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Arms
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 50 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
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.

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03011957

Locations

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

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

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

More Information


Responsible Party: Monty Montano, Director, Muscle and Aging Interventions, Brigham and Women's Hospital  
ClinicalTrials.gov Identifier: NCT03011957   History of Changes  
Other Study ID Numbers: 2014P002489  
Study First Received: December 12, 2016  
Last Updated: January 16, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this data on September 20, 2018
This information is provided by ClinicalTrials.gov.