NCT06554210

Brief Summary

RATIONALE: HIV pathology has been associated with accelerated aging of the infected organism, with no known knowledge of virus, immunosuppression, immune response stimulation, antiretroviral toxicity, and "classic" risks. The data are in good standing from a multicenter cohort with high statistical power but very heterogeneous and not exhaustive. A complementary approach by small, comprehensive cohorts is desirable. POPULATION CONCERNED: HIV-positive persons OBJECTIVE To describe the aging of the physiological functions of people living with HIV. SECONDARY OBJECTIVES Assess the determinants (virus / HAART / Immunity / environment) Compare to the general population (historical comparisons) Compare to main body functions MAIN EVALUATION CRITERIA respiratory functional tests, memory test, IMTc, ECG, creatininemia, cancer, Fibroscan, bone densitometry... SECONDARY EVALUATION CRITERIA Age, sex, phototype, CD4 lymphocytes count, viral load, nadir CD4, antiretroviral exposure, alcohol, tobacco ... METHODOLOGY Monocentric retrospective study STATISTICS Frailty model, chi2 test, test U INCLUSION CRITERIA Seropositive for HIV, age\>18 years Follow-up at least once in the Internal Medicine department between 1995 and 2018 CRITERIA OF EXCLUSION Refusal of the patient or unreachable patient NUMBER OF PATIENTS Between 200 and 300 CALENDAR Duration of inclusions: 3 months Duration of participation of the patient: 20 years (retrospectives ...) Duration of the study: 1 year

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
5.9 years until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

October 1, 2018

Last Update Submit

August 13, 2024

Conditions

Keywords

AgingHIV

Outcome Measures

Primary Outcomes (7)

  • renal aging

    creatinin level, creatinin clearance, microalbuminuria

    yearly

  • pulmonary aging

    respiratory functional test

    at last one

  • liver aging

    elastometry (Fibroscan\*)

    at last one

  • neurological aging

    memory tests

    at last one

  • vascular aging

    intima-media thickness, systolic and diastolic blood pressure

    at last one

  • Bone aging

    osteodensitometry

    at last one

  • heart aging

    ECG, echography

    at last one

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All persons followed between 2003 to 2018 in the one center (Internal Médicine) of the West Brittany cohort

You may qualify if:

  • HIV positive persons followed in Internal Medicine departement of Brest University Hospital

You may not qualify if:

  • opposition of the study
  • \<18 ans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine Department of University Hospital

Brest, 29200, France

Location

MeSH Terms

Conditions

Aging, PrematureHIV Infections

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Luc de Saint-Martin, MD, PhD

    University Hospital, Brest

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

August 15, 2024

Study Start

January 8, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations