NCT04067219

Brief Summary

this study consists of the study of markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

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

May 3, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2013

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2013

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 21, 2019

Last Update Submit

August 22, 2019

Conditions

HIV-1-infectionMarker; Structural

Keywords

Alterations

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters

    presence of osteoporosis or osteopenia on DXA (T-score \< -2.5 and \<-1, respectively), locomotor test results \> 2 standard deviations of the mean of the general population, presence of premature hair whitening in patients aged \< 40 years (defined by\>50% of gray hair before the age of 40)

    At the earliest at the inclusion visit and within a 9-month window after inclusion

Study Arms (1)

Single arm

EXPERIMENTAL

HIV-1 infected patients

Procedure: DXA (dual-energy x-ray absorptiometric) measurement

Interventions

DXA (dual-energy x-ray absorptiometric) measurementPROCEDURE

DXA, evaluation of muscular function and muscle strength; neurocognitive tests; non invasive analysis of mechanical skin properties; food frequency questionnaire; laboratory assessment (25 hydroxy vitamin D, calcium/phosphate metabolism, bone remodelling markers, T cell activation).

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infected patients included in the TISSOS-VIH substudy of the ARNS CO3 Aquitaine Cohort or who had a DXA measurement of the lumbar spine, femoral neck, and total body between 2004 and 2011 at the University Hospital of Bordeaux,
  • \> 18 years
  • Affiliated to the medical insurance
  • Having had at least one DXA measurement prior to the SIMBAD study visit
  • Written informed consent for the SIMBAD study

You may not qualify if:

  • Hepatitis C virus co-infection
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Absorptiometry, PhotonWeights and Measures

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Patrick MERCIE, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

May 3, 2012

Primary Completion

January 3, 2013

Study Completion

December 19, 2013

Last Updated

August 26, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share