Clinical trial NCT03011957: Biomarkers for Muscle Function and Aging in Chronic HIV Infection
Official title: Biomarkers for Muscle Function and Aging in Chronic HIV Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Inflammation at baseline and 3 years
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Womens Hospital
name: Monty A Montano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.