Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65

Hiv Clinical Trial

— ALTER  

Official title:

Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04321603
• Other study ID #: HP-00089501
• Status: Withdrawn
• Phase: N/A
• Start date: May 30, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: August 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People living with HIV are living longer as their disease is controlled with antiretroviral medications. Yet they are experiencing frailty more often and more than ten years earlier than those without HIV. In elderly persons without HIV, frailty is associated with decreased muscle strength and chronic inflammation. Less is known about what is driving early frailty in HIV or effective prevention measures for aging adults with HIV.

It may be that having HIV infection impairs energy production by mitochondria within the cells and contributes to the muscle weakness and inflammation accompanying frailty in people living with HIV . This study will examine the impact of six weeks of moderately paced walking on energy production in the cells, inflammation markers and frailty scores in people living with well-controlled HIV who are aged 50 to 65.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults aged 50 to 65

• Documentation of HIV infection from Medical Provider

• Currently receiving antiretrovirals

• HIV viral load less than 50 iu/mL for at least six months

• CD4 count at least 350 cell/mm3 for the last six months

• Willing and able to walk at least 30 minutes 3 times weekly within 30 minutes of UMB

• Speaks English

Exclusion Criteria:

• Current smokers

• Weight less than 110 pounds

• Subjects taking long-term corticosteroids equivalent to 10mg/day or more, or immunomodulators

• Subjects with conditions known to affect inflammatory or mitochondrial function other than HIV, such as rheumatoid arthritis, gout, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, Parkinson's disease, Alzheimer's disease, active hepatitis, sleep apnea or autoimmune diseases.

• Current drug or alcohol use or dependence or unstable mental health conditions that, in the opinion of the investigator, would interfere with adherence to study requirements

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome
• Hiv

Intervention

Behavioral:
• Walking
Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frailty Related Phenotype	Change in frailty phenotype score (0-5 with 3 to 5 indicating frailty) after a six-week walking intervention	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Primary	Mitochondrial Respiration PBMC and platelets	Change in mitochondrial respiratory capacity after a six-week walking intervention	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Secondary	Inflammation IL-1ß	Change in IL-1ß after a six-week walking intervention	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
Secondary	Inflammation IL-6	Change in IL-6 after a six-week walking intervention	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Secondary	Inflammation IL-10	Change in IL-10 after a six-week walking intervention	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Secondary	Inflammation TNF-a	Change in TNF-a after a six-week walking intervention	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Secondary	Inflammation hsCRP	Change in hsCRP after a six-week walking intervention	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12