Biomarkers for Muscle Function and Aging in Chronic HIV Infection

HIV Clinical Trial

— MATCH  

Official title:

Biomarkers for Muscle Function and Aging in Chronic HIV Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03011957
• Other study ID #: 2014P002489
• Status: Active, not recruiting
• Phase: N/A
• First received: December 12, 2016
• Last updated: January 16, 2018
• Start date: February 2015
• Est. completion date: February 2020

Study information

• Verified date: January 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: February 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tran T, Guardigni V, Pencina KM, Amato AA, Floyd M, Brawley B, Mozeleski B, McKinnon J, Woodbury E, Heckel E, Li Z, Storer T, Sax PE, Montano M. Atypical Skeletal Muscle Profiles in HIV+ Asymptomatic Middle-Aged Adults. Clin Infect Dis. 2017 Dec 25. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation at baseline and 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