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TerminatedNCT04067219SIMBADUpdated Jun 24, 2026

SkIn, Muscle and Bone Aging Determinants in HIV Infected-patients.

An interventional study of DXA (dual-energy x-ray absorptiometric) measurement in HIV-1-infection and Marker; Structural, sponsored by University Hospital, Bordeaux. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Basic science

Why this study was terminated
target number of patient not reached

From the registry’s dates

  • Registered 7 years 3 months after the study started (first participant enrolled May 2012, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
123
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Nowadays, the elevated frequency of cancers as well as cardiovascular, neurocognitive and bone diseases seems to denote a process of accelerated aging in the treated HIV-infected population of western countries, who are 40 to 50 years old in median. Markers of age-related alterations should be compared to the distribution among the general population whenever possible, to disentangle the effect of HIV and "normal" ageing or ageing due to other conditions. Common mechanisms should be better understood, more specifically those related to the impact of tobacco, antiretroviral treatments, and nutritional components. For markers of skin, muscle, neurocognitive function and bone ageing, the distribution of the general population is available and, in addition, alteration of these markers might have common mechanisms, such as insufficiency in 25 hydroxy vitamin D or nutritional parameters. Therefore, a joint study of these three organs seems particularly relevant.

This aim is to study 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.

02

Conditions studied

  • HIV-1-infection
  • Marker; Structural

Keywords

  • Alterations
03

In context

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Hepatitis C virus co-infection
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Single arm

    HIV-1 infected patients

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

Interventions

  • ProcedureDXA (dual-energy x-ray absorptiometric) measurement

    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).

06

What researchers measure

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)

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04067219
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Aug 26, 2019
Start date
May 3, 2012
Primary completion
Jan 3, 2013
Completion
Dec 19, 2013
Last update
Jun 24, 2026

Study contacts

Patrick MERCIE, Pr
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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