Biomarkers for Muscle Function and Aging in Chronic HIV I... | NCT03011957

Studies
Biomarkers for Muscle Function and Aging in Chronic HIV Infection

NCT03011957

Sponsor

Brigham and Women's Hospital

Status

Unknown status

Last Update Posted

Jan 18, 2018Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Feb 2019Estimated

Completion Date

Feb 2020Estimated

First Submitted Date

Dec 12, 2016

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 6, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2018

Last Update Posted Date

Jan 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

160Actual

Label	Type	Description	Intervention Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Monty A Montano, PhD	Brigham and Womens Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29293942	Result	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.