HivALTERNCT04321603
Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65
A study testing Walking in people with Hiv and Frailty Syndrome, run by University of Maryland, Baltimore.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Hiv, Frailty Syndrome
- What is being tested?
- Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2020to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Hiv, Frailty Syndrome
- Being tested
- Walking
- Keywords
- physical activity, mitochondrial respiration, inflammation
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Frailty, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
Also called physical activity
Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV | Other | Subjects will act as own control between Visit one and Visit two, then will complete six weeks of walking, 30 minutes per walk, three times weekly between Visit Two and Visit Three. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial Respiration PBMC and platelets
Change in mitochondrial respiratory capacity after a six-week walking intervention
Measured: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Secondary outcomes (5)
Inflammation IL-1β
Change in IL-1β after a six-week walking intervention
Measured: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
Inflammation IL-6
Change in IL-6 after a six-week walking intervention
Measured: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Inflammation IL-10
Change in IL-10 after a six-week walking intervention
Measured: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Inflammation TNF-α
Change in TNF-α after a six-week walking intervention
Measured: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Inflammation hsCRP
Change in hsCRP after a six-week walking intervention
Measured: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start30 May 2020
- Primary completion30 May 2020
- Study completion30 May 2020
Why it stopped: COVID-19 prevented us from doing this human subjects study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This within-subjects design will allow each subject to be utilized as their own control pre-intervention. With expectation of great inter-person variability of oxygen consumption results, this design will incorporate less error than separately recruited controls and decrease the needed sample size.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Klinedinst, University of Maryland, Baltimore
- Investigators
- Jennifer Klinedinst, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321603
- Sponsor's protocol ID
- HP-00089501
- Acronym
- ALTER
- Status last verified
- Aug 2021
- First submitted
- 19 Mar 2020
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65
- ClinicalTrials.gov ID
- NCT04321603
- Acronym / sponsor ID
- ALTER / HP-00089501
- Conditions
- Hiv, Frailty Syndrome
- Keywords
- physical activity, mitochondrial respiration, inflammation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 prevented us from doing this human subjects study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This within-subjects design will allow each subject to be utilized as their own control pre-intervention. With expectation of great inter-person variability of oxygen consumption results, this design will incorporate less error than separately recruited controls and decrease the needed sample size.
| Arm | Type | Receives |
|---|---|---|
| People living with HIV | Other | Behavioral: WalkingSubjects will act as own control between Visit one and Visit two, then will complete six weeks of walking, 30 minutes per walk, three times weekly between Visit Two and Visit Three. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkingAlso: physical activityModerately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks. | Behavioural | People living with HIV |
Primary outcome
Mitochondrial Respiration PBMC and platelets
Time frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Change in mitochondrial respiratory capacity after a six-week walking intervention
5 secondary outcomes
Inflammation IL-1β
Time frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
Inflammation IL-6
Time frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Inflammation IL-10
Time frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Inflammation TNF-α
Time frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Inflammation hsCRP
Time frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Klinedinst, PhD principal investigator
Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing Walking in people with Hiv and Frailty Syndrome, run by University of Maryland, Baltimore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial Respiration PBMC and platelets (time frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.