Biomarkers for Muscle Function and Aging in Chronic HIV Infection

NCT03011957 | Unknown

• 1 other identifier: 2014P002489
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Group 1: HIV positive subjects
• HIV positive
• English speaking
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

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

  PMID: 29293942 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, muscle biopsy

Study Officials

• Monty A Montano, PhD

  Brigham and Womens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Muscle and Aging Interventions

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: January 6, 2017
• Study Start: February 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2020
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)