Spanish Cohort of Patients with HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function

NCT03558438 | Active Not Recruiting

• 1 other identifier: GESIDA 9817
• Study Type: observational
• Target: 802
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

HIV Infections; Frail Older Adults

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  Year 5

• To study the prognostic value of the CD4 / CD8 ratio in relation to frailty

  Change from Basal to Year 5

• Analyze the relationship between exposure time to different families of antiretroviral drugs with fragility.

  Change from Basal to Year 5

• Define fragility biomarkers

  immunological profile, oxidative damage, microbiome.

  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

  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

  Year 1, year 2, year 3, year 4 and year 5

• To know the prevalence of other geriatric syndromes

  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

  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

  Year 1, year 2, year 3, year 4 and year 5

Study Arms (1)

HIV patients older than 50 years

Spanish cohort of patients with HIV infection older tha 50 years old.

Other: No interventions

Interventions

No interventions OTHER

No interventions

HIV patients older than 50 years

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead

Study Sites (13)

Hospital Reina Sofia

Córdoba, Córdoba, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Donostia, Spain

Location

Clínico San Carlos

Madrid, Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

Hospital Univ. La Paz

Madrid, Madrid, Spain

Location

Hospital de Santiago

Santiago de Compostela, Santiago de Compostela, Spain

Location

Hospital Clínic de Valencia

Valencia, Valencia, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Spain

Location

Hospital de Guadalajara

Guadalajara, Spain

Location

Hospital Fundación Jimenez Diaz

Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Spain

Location

Hospital Infanta Leonor

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 36597036 DERIVED

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

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 15, 2018
• Study Start: May 7, 2018
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

ES (13)