HIVCHAINNCT01186042
Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)
An observational study of HIV and Aging, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to find the best tests to use to investigate the differences between older and younger people with HIV disease. Test to be included will measures of memory, learning, activity levels, sleep patterns, emotional well-being and sexual health. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- What is being tested?
- Observational
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2010to 17 Dec 2014
- Phase
- Observational
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University of Nebraska Medical Center HIV Clinic
Who may be able to join
- Diagnosed with HIV infection.
- 20-40 years of age or older than 50.
- If taking antiretroviral therapy, on stable therapy for the past 12 weeks and not anticipated to require a change in therapy during the following 6 weeks.
- If not taking antiretroviral therapy, not anticipated to initiate therapy in the next 6 weeks.
- Ability to provide written informed consent.
- Ability to complete the questionnaires in English.
Who cannot join
- Completion of treatment for any intercurrent acute infection less than four weeks before study entry. Maintenance or prophylactic therapy is permitted for opportunistic infections.
- Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound performance of or the analysis of the test results.
- Active drug or alcohol abuse that, in the investigator's opinion, could compromise compliance with study procedures or confound the analysis of the test results.
- Major neurologic disease such as multiple sclerosis or stroke, active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
- Current delirium or intoxication.
- Pregnancy.
- Any other condition that, in the opinion of the investigator, is a contraindication to participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
The purpose of this study is to find the best tests to use to investigate the differences between older and younger people with HIV disease. Test to be included will measures of memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.
Read the detailed description
Advances in the treatment of chronic HIV disease over the last 20 years have resulted in dramatic declines in morbidity and mortality. However, emerging data suggest that chronically infected patients may be aging prematurely, and/or experience increased incidence of age-related conditions. These phenomena are poorly understood. The overall goal of the CHAIN project is to support the expansion of innovative research on the effects of chronic HIV infection, co-morbidities, and aging on the central nervous system (CNS). We propose the initiation of a clinical portion to better understand the nature of the aging process in HIV-infected patients, with an emphasis on brain disease. This is a pilot, feasibility study to inform the design of a larger, prospective cohort study.
We plan to enroll 20 older HIV-infected patients (more than 50 years old) and 20 younger controls (20-40 years old), matched for gender and race/ethnicity. Participants will undergo a series of tests, at one comprehensive assessment. Demographic and medical history data will be abstracted from the medical record. Each participant will undergo a medical history and physical examination, and a battery of tests designed to evaluate neuropsychological function, activity, sleep patterns, frailty, emotional well-being and sexual health. These will consist of self-administered questionnaires and neuropsychological tests, as detailed in the Methods section. Innovative measures will be included such as an activity monitor worn by participants, and a Wii balance board to assess standing balance. Participants will be asked to keep a diary and wear the activity monitoring device for one month. Plasma and serum samples will be collected on one occasion for future testing of potential biomarkers.
- Being tested
- Observational
- Keywords
- HIV, Aging, Neuropsychological function, Activity, Sleep patterns, Frailty, Emotional well-being, Sexual health
- Medical subject headings
- Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Aging in HIV | 20-40 years of age or older than 50 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of enrolling older HIV-infected patients and younger controls into a prospective, observational study.
Evaluate the feasibility of enrolling older HIV-infected patients and youger controls into a prospective, observational study.
Measured: One month
Secondary outcomes (3)
Selection of the optimal test battery to measure the areas of interest
Secondary objective includes:
Selection of the optimal test battery to measure the areas of interest;
Measured: One month
Participant acceptance of the measures involved
Secondary objective includes:
Participant acceptance of the measures involved;
Measured: One month
Preliminary data collection to inform the size and design of a larger, follow-up study.
Secondary objective includes:
Preliminary data collection to inform the size and design of a larger, follow-up study.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study start1 Aug 2010
- Primary completion17 Dec 2014
- Study completion17 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Susan Swindells, MBBS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186042
- Sponsor's protocol ID
- 0396-10-FB
- Other IDs
- P30MH062261
- Acronym
- CHAIN
- Status last verified
- Sep 2023
- First submitted
- 22 Jul 2010
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Valcour V, Shikuma C, Shiramizu B, Watters M, Poff P, Selnes O, Holck P, Grove J, Sacktor N. Higher frequency of dementia in older HIV-1 individuals: the Hawaii Aging with HIV-1 Cohort. Neurology. 2004 Sep 14;63(5):822-7. doi: 10.1212/01.wnl.0000134665.58343.8d.
PubMed 15365130
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)
- ClinicalTrials.gov ID
- NCT01186042
- Acronym / sponsor ID
- CHAIN / 0396-10-FB
- Keywords
- HIV, Aging, Neuropsychological function, Activity, Sleep patterns, Frailty, Emotional well-being, Sexual health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 17 Dec 2014 (actual)
- Study completion
- 17 Dec 2014 (actual)
- First posted
- 20 Aug 2010 (estimated)
- 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.
The purpose of this study is to find the best tests to use to investigate the differences between older and younger people with HIV disease. Test to be included will measures of memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.
Detailed description
Advances in the treatment of chronic HIV disease over the last 20 years have resulted in dramatic declines in morbidity and mortality. However, emerging data suggest that chronically infected patients may be aging prematurely, and/or experience increased incidence of age-related conditions. These phenomena are poorly understood. The overall goal of the CHAIN project is to support the expansion of innovative research on the effects of chronic HIV infection, co-morbidities, and aging on the central nervous system (CNS). We propose the initiation of a clinical portion to better understand the nature of the aging process in HIV-infected patients, with an emphasis on brain disease. This is a pilot, feasibility study to inform the design of a larger, prospective cohort study.
We plan to enroll 20 older HIV-infected patients (more than 50 years old) and 20 younger controls (20-40 years old), matched for gender and race/ethnicity. Participants will undergo a series of tests, at one comprehensive assessment. Demographic and medical history data will be abstracted from the medical record. Each participant will undergo a medical history and physical examination, and a battery of tests designed to evaluate neuropsychological function, activity, sleep patterns, frailty, emotional well-being and sexual health. These will consist of self-administered questionnaires and neuropsychological tests, as detailed in the Methods section. Innovative measures will be included such as an activity monitor worn by participants, and a Wii balance board to assess standing balance. Participants will be asked to keep a diary and wear the activity monitoring device for one month. Plasma and serum samples will be collected on one occasion for future testing of potential biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aging in HIV | – | Other: Observational20-40 years of age or older than 50 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University of Nebraska Medical Center HIV Clinic
Key inclusion criteria (6 listed)
- Diagnosed with HIV infection.
- 20-40 years of age or older than 50.
- If taking antiretroviral therapy, on stable therapy for the past 12 weeks and not anticipated to require a change in therapy during the following 6 weeks.
- If not taking antiretroviral therapy, not anticipated to initiate therapy in the next 6 weeks.
- Ability to provide written informed consent.
Key exclusion criteria (7 listed)
- Completion of treatment for any intercurrent acute infection less than four weeks before study entry. Maintenance or prophylactic therapy is permitted for opportunistic infections.
- Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound performance of or the analysis of the test results.
- Active drug or alcohol abuse that, in the investigator's opinion, could compromise compliance with study procedures or confound the analysis of the test results.
- Major neurologic disease such as multiple sclerosis or stroke, active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
- Current delirium or intoxication.
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 |
|---|---|---|
| ObservationalNo intervention | Other | Aging in HIV |
Primary outcome
Evaluate the feasibility of enrolling older HIV-infected patients and younger controls into a prospective, observational study.
Time frame: One month
Evaluate the feasibility of enrolling older HIV-infected patients and youger controls into a prospective, observational study.
3 secondary outcomes
Selection of the optimal test battery to measure the areas of interest
Time frame: One month
Participant acceptance of the measures involved
Time frame: One month
Preliminary data collection to inform the size and design of a larger, follow-up study.
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 15365130Valcour V, Shikuma C, Shiramizu B, Watters M, Poff P, Selnes O, Holck P, Grove J, Sacktor N. Higher frequency of dementia in older HIV-1 individuals: the Hawaii Aging with HIV-1 Cohort. Neurology. 2004 Sep 14;63(5):822-7. doi: 10.1212/01.wnl.0000134665.58343.8d.
- University of Nebraska Medical Center HIV ClinicLink provided by the sponsor.
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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.
Susan Swindells, MBBS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Aging, run by University of Nebraska at 1 site in United States.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the feasibility of enrolling older HIV-infected patients and younger controls into a prospective, observational study. (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186042, which also lists 1 linked publication.
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 6 Sep 2023.