Spanish Cohort of Patients With HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function (FUNCFRAIL)

• ClinicalTrials.gov Identifier: NCT03558438
• Recruitment Status: Active, not recruiting
• First Posted: June 15, 2018
• Last Update Posted: February 5, 2020
• Sponsor: Fundacion SEIMC-GESIDA
• Information provided by (Responsible Party): Fundacion SEIMC-GESIDA

Study Description

Brief Summary:

It's a prospective observational study to assess frailty and physical function

Condition or disease	Intervention/treatment
HIV Infections; Frail Older Adults	Other: No interventions

Detailed Description:

We stimate to recruit 1120 patients older tan 50 years to assess frailty and define a simplified fragility index

Study Design

• Study Type: Observational
• Actual Enrollment: 802 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Spanish Cohort of Patients With HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function
• Actual Study Start Date: May 7, 2018
• Estimated Primary Completion Date: May 31, 2023
• Estimated Study Completion Date: May 31, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
HIV patients older than 50 years; Spanish cohort of patients with HIV infection older tha 50 years old.	Other: No interventions; No interventions

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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
3. To study the prognostic value of the CD4 / CD8 ratio in relation to frailty [ Time Frame: Change from Basal to Year 5 ]
4. Analyze the relationship between exposure time to different families of antiretroviral drugs with fragility. [ Time Frame: Change from Basal to Year 5 ]
5. Define fragility biomarkers [ Time Frame: Change from Basal to Year 5 ]
   immunological profile, oxidative damage, microbiome.

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. To know the prevalence of other geriatric syndromes [ Time Frame: Year 1, year 2, year 3, year 4 and year 5 ]
   polypharmacy, falls, cognitive impairment, depression, risk of malnutrition.
4. 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 ]
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 ]

Biospecimen Retention:   Samples With DNA

Markers of mitochondrial function, of naive cells, memory and recent immigrants of the thymus, of immunoactivation, immunosenescence, activation / exhaustion and proliferation and Telomere measurement

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with HIV infection older ythan 50 year sold who are followed in the consultations of the center participants

Criteria

Inclusion Criteria:

1. Patients with confirmed HIV + infection.

2. 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.

3. Have signed the informed consent and be willing to comply with the study visits.

Exclusion Criteria:

1. Have an established disability that does not allow you to walk.
2. Patients who can not comply with the visits and study procedures or who are not usually followed at the center.

Contacts and Locations

Locations

Spain

Hospital Germans Trias i Pujol

Barcelona, Spain

Hospital Reina Sofia

Córdoba, Spain

Hospital de Donostia

Donostia, Spain

Hospital de Guadalajara

Guadalajara, Spain

Clínico San Carlos

Madrid, Spain

Hospital Fundación Jimenez Diaz

Madrid, Spain

Hospital Gregorio Marañón

Madrid, Spain

Hospital Infanta Leonor

Madrid, Spain

Hospital Puerta de Hierro

Madrid, Spain

Hospital Ramón y Cajal

Madrid, Spain

Hospital Univ. La Paz

Madrid, Spain

Hospital de Santiago

Santiago De Compostela, Spain

Hospital Clínic de Valencia

Valencia, Spain

Sponsors and Collaborators

Fundacion SEIMC-GESIDA

More Information

• Responsible Party: Fundacion SEIMC-GESIDA
• ClinicalTrials.gov Identifier: NCT03558438
• Other Study ID Numbers: GESIDA 9817
• First Posted: June 15, 2018
• Last Update Posted: February 5, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Disease Attributes; Pathologic Processes; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases