Clinical trial NCT03558438: Spanish Cohort of Patients with HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function
Official title: Spanish Cohort of Patients with HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Infections
Frail Older Adults
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 802
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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

Eligibility 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.

Primary outcomes:
measure: To know the prevalence of frailty in the population over 50 years old with HIV infection according to Fried's fragility phenotype
timeFrame: Change from basal to year 5
measure: Define a new simplified fragility index for the elderly patients with HIV infection easily applicable in clinical routine practice
timeFrame: Year 5
measure: To study the prognostic value of the CD4 / CD8 ratio in relation to frailty
timeFrame: Change from Basal to Year 5
measure: Analyze the relationship between exposure time to different families of antiretroviral drugs with fragility.
timeFrame: Change from Basal to Year 5
measure: Define fragility biomarkers
timeFrame: Change from Basal to Year 5
Secondary outcomes:
measure: Know the functional situation and the risk of functional deterioration of the population over 50 years of age with HIV infection in our cohort
timeFrame: Year 1, year 2, year 3, year 4 and year 5
measure: Analyze the possible association of fragility in this population group with the comorbidity and the presence of other geriatric syndromes
timeFrame: Year 1, year 2, year 3, year 4 and year 5
measure: To know the prevalence of other geriatric syndromes
timeFrame: Year 1, year 2, year 3, year 4 and year 5
measure: To know the risk of fragility fractures in the population over 50 years old with HIV infection in our cohort
timeFrame: Year 1, year 2, year 3, year 4 and year 5
measure: To analyze the possible association of bone fragility with the presence of the syndrome clinical of fragility in this population group
timeFrame: Year 1, year 2, year 3, year 4 and year 5
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Donostia
country: Spain
facility: Hospital de Donostia
city: Guadalajara
country: Spain
facility: Hospital de Guadalajara
city: Madrid
country: Spain
facility: Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Univ. La Paz
city: Santiago De Compostela
country: Spain
facility: Hospital de Santiago
city: Valencia
country: Spain
facility: Hospital Clínic de Valencia
Study officials:
References: