HIV InfectionsFUNCFRAILNCT03558438
Spanish Cohort of Patients with HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function
An observational study of HIV Infections and Frail Older Adults, run by Fundacion SEIMC-GESIDA at 13 sites in Spain.
Trial summary
It's a prospective observational study to assess frailty and physical function Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV Infections, Frail Older Adults
- How many people
- 802 participants
- Where
- 13 sitesSpain
- Study dates
- 7 May 2018to 31 May 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HIV infection older ythan 50 year sold who are followed in the consultations of the center participants
Who may be able to join
- Patients with confirmed HIV + infection.
- Patients aged ≥ 50 years at the time of starting the study, followed in the Infectious-HIV consultations of the centers participants.
- This limit has been chosen because it is accepted by the scientific community for define the elderly patient in patients with HIV infection.
- Have signed the informed consent and be willing to comply with the study visits.
Who cannot join
- Have an established disability that does not allow you to walk.
- Patients who can not comply with the visits and study procedures or who are not usually followed at the center.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital Germans Trias i Pujol
Barcelona
Hospital Reina Sofia
Córdoba, Córdoba
Hospital de Donostia
Donostia / San Sebastian, Donostia
Hospital de Guadalajara
Guadalajara
Clínico San Carlos
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
Hospital Univ. La Paz
Madrid, Madrid
Hospital Fundación Jimenez Diaz
Madrid
Hospital Gregorio Marañón
Madrid
Hospital Infanta Leonor
Madrid
Hospital Puerta de Hierro
Madrid
Hospital de Santiago
Santiago de Compostela, Santiago de Compostela
Hospital Clínic de Valencia
Valencia, Valencia
About this study
It's a prospective observational study to assess frailty and physical function
Read the detailed description
We stimate to recruit 1120 patients older tan 50 years to assess frailty and define a simplified fragility index
- Conditions
- HIV Infections, Frail Older Adults
- Being tested
- No interventions
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| HIV patients older than 50 years | Spanish cohort of patients with HIV infection older tha 50 years old. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
To know the prevalence of frailty in the population over 50 years old with HIV infection according to Fried's fragility phenotype
Fragility is defined according to the 5 Fried criteria:
- Involuntary weight loss: (> 4.5Kg in the last year)
- Declined mood: through two questions from the Scale for Depression of the Center for Epidemiological Studies (CES-D).
- Speed of walking adjusted for height and sex,
- Weekly physical activity adjusted by sex.
- Muscle weakness according to manual grip strength adjusted for BMI and sex.
Measured: Change from basal to year 5
Define a new simplified fragility index for the elderly patients with HIV infection easily applicable in clinical routine practice
The simplified fragility index for the elderly patient with HIV infection can not be defined a priori, so a multivariate logistic regression analysis will be performed for those variables that are associated with fragility in the analysis univariate, which will allow us to determine the variables that are associated in a independent with fragility, which will be with which we will define the fragility index simplified. Fragility will be treated as a binary variable: pre-fragile and robust will form a group that will serve as control. The fragility phenotype defined by the 5 Fried criteria will be considered the gold standard test to measure fragility when validating the simplified fragility screening test specific for elderly patients with HIV infection that we want to define
Measured: Year 5
To study the prognostic value of the CD4 / CD8 ratio in relation to frailty
Measured: Change from Basal to Year 5
Analyze the relationship between exposure time to different families of antiretroviral drugs with fragility.
Measured: Change from Basal to Year 5
Define fragility biomarkers
immunological profile, oxidative damage, microbiome.
Measured: Change from Basal to Year 5
Secondary outcomes (5)
Know the functional situation and the risk of functional deterioration of the population over 50 years of age with HIV infection in our cohort
Measured: Year 1, year 2, year 3, year 4 and year 5
Analyze the possible association of fragility in this population group with the comorbidity and the presence of other geriatric syndromes
Measured: Year 1, year 2, year 3, year 4 and year 5
To know the prevalence of other geriatric syndromes
polypharmacy, falls, cognitive impairment, depression, risk of malnutrition.
Measured: Year 1, year 2, year 3, year 4 and year 5
To know the risk of fragility fractures in the population over 50 years old with HIV infection in our cohort
Measured: Year 1, year 2, year 3, year 4 and year 5
To analyze the possible association of bone fragility with the presence of the syndrome clinical of fragility in this population group
Measured: Year 1, year 2, year 3, year 4 and year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start7 May 2018
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
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 HIV InfectionsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558438
- Sponsor's protocol ID
- GESIDA 9817
- Acronym
- FUNCFRAIL
- Status last verified
- Aug 2024
- First submitted
- 25 May 2018
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Branas F, Torralba M, Antela A, Vergas J, Ramirez M, Ryan P, Dronda F, Galindo MJ, Machuca I, Bustinduy MJ, Cabello A, Montes ML, Sanchez-Conde M; FUNCFRAIL study group. Effects of frailty, geriatric syndromes, and comorbidity on mortality and quality of life in older adults with HIV. BMC Geriatr. 2023 Jan 3;23(1):4. doi: 10.1186/s12877-022-03719-8.
PubMed 36597036
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Cohort of Patients with HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function
- ClinicalTrials.gov ID
- NCT03558438
- Acronym / sponsor ID
- FUNCFRAIL / GESIDA 9817
- Conditions
- HIV Infections, Frail Older Adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 15 Jun 2018 (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.
It's a prospective observational study to assess frailty and physical function
Detailed description
We stimate to recruit 1120 patients older tan 50 years to assess frailty and define a simplified fragility index
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV patients older than 50 years | – | Other: No interventionsSpanish cohort of patients with HIV infection older tha 50 years old. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HIV infection older ythan 50 year sold who are followed in the consultations of the center participants
Key inclusion criteria (4 listed)
- Patients with confirmed HIV + infection.
- Patients aged ≥ 50 years at the time of starting the study, followed in the Infectious-HIV consultations of the centers participants.
- This limit has been chosen because it is accepted by the scientific community for define the elderly patient in patients with HIV infection.
- Have signed the informed consent and be willing to comply with the study visits.
Key exclusion criteria (2 listed)
- Have an established disability that does not allow you to walk.
- Patients who can not comply with the visits and study procedures or who are not usually followed at the center.
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 |
|---|---|---|
| No interventionsNo interventions | Other | HIV patients older than 50 years |
Primary outcome
To know the prevalence of frailty in the population over 50 years old with HIV infection according to Fried's fragility phenotype
Time frame: Change from basal to year 5
Fragility is defined according to the 5 Fried criteria: * Involuntary weight loss: (> 4.5Kg in the last year) * Declined mood: through two questions from the Scale for Depression of the Center for Epidemiological Studies (CES-D). * Speed of walking adjusted for height and sex, * Weekly physical activity adjusted by sex. * Muscle weakness according to manual grip strength adjusted for BMI and sex.
Define a new simplified fragility index for the elderly patients with HIV infection easily applicable in clinical routine practice
Time frame: Year 5
The simplified fragility index for the elderly patient with HIV infection can not be defined a priori, so a multivariate logistic regression analysis will be performed for those variables that are associated with fragility in the analysis univariate, which will allow us to determine the variables that are associated in a independent with fragility, which will be with which we will define the fragility index simplified. Fragility will be treated as a binary variable: pre-fragile and robust will form a group that will serve as control. The fragility phenotype defined by the 5 Fried criteria will be considered the gold standard test to measure fragility when validating the simplified fragility screening test specific for elderly patients with HIV infection that we want to define
To study the prognostic value of the CD4 / CD8 ratio in relation to frailty
Time frame: Change from Basal to Year 5
Analyze the relationship between exposure time to different families of antiretroviral drugs with fragility.
Time frame: Change from Basal to Year 5
Define fragility biomarkers
Time frame: Change from Basal to Year 5
immunological profile, oxidative damage, microbiome.
5 secondary outcomes
Know the functional situation and the risk of functional deterioration of the population over 50 years of age with HIV infection in our cohort
Time frame: Year 1, year 2, year 3, year 4 and year 5
Analyze the possible association of fragility in this population group with the comorbidity and the presence of other geriatric syndromes
Time frame: Year 1, year 2, year 3, year 4 and year 5
To know the prevalence of other geriatric syndromes
Time frame: Year 1, year 2, year 3, year 4 and year 5
To know the risk of fragility fractures in the population over 50 years old with HIV infection in our cohort
Time frame: Year 1, year 2, year 3, year 4 and year 5
To analyze the possible association of bone fragility with the presence of the syndrome clinical of fragility in this population group
Time frame: Year 1, year 2, year 3, year 4 and year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Derived from this study: PubMed 36597036Branas F, Torralba M, Antela A, Vergas J, Ramirez M, Ryan P, Dronda F, Galindo MJ, Machuca I, Bustinduy MJ, Cabello A, Montes ML, Sanchez-Conde M; FUNCFRAIL study group. Effects of frailty, geriatric syndromes, and comorbidity on mortality and quality of life in older adults with HIV. BMC Geriatr. 2023 Jan 3;23(1):4. doi: 10.1186/s12877-022-03719-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Frail Older Adults, run by Fundacion SEIMC-GESIDA at 13 sites in Spain.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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?
Results are not available in the source record.
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?
To know the prevalence of frailty in the population over 50 years old with HIV infection according to Fried's fragility phenotype (time frame: Change from basal to year 5). The study lists 5 primary outcomes in all. 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 NCT03558438, 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 3 Sep 2024.