Biomarkers for Muscle Function and Aging in Chronic HIV Infection

NCT ID: NCT03011957

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2020-02-29

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.

Conditions

HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

HIV positive viral load \< 200 copies/ml 50-65 years old CD4 \> 350 cells/ml Male or Female

No interventions assigned to this group

Group 2

HIV negative 50-65 years old CD4 \> 350 cells/ml Male or Female

No interventions assigned to this group

Eligibility 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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Monty Montano

Director, Muscle and Aging Interventions

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monty A Montano, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Womens Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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 Human Immunodeficiency Virus-Infected Asymptomatic Middle-Aged Adults. Clin Infect Dis. 2018 Jun 1;66(12):1918-1927. doi: 10.1093/cid/cix1121.

Reference Type: RESULT

PMID: 29293942 (View on PubMed)

Other Identifiers

2014P002489

Identifier Type: -

Identifier Source: org_study_id