HIV-1-infectionSIMBADNCT04067219
SkIn, Muscle and Bone Aging Determinants in HIV Infected-patients.
A study testing DXA (dual-energy x-ray absorptiometric) measurement in people with HIV-1-infection and Marker; Structural, run by University Hospital, Bordeaux.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, Marker; Structural
- What is being tested?
- DXA (dual-energy x-ray absorptiometric) measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2012to 19 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hepatitis C virus co-infection
- Pregnancy
About this study
Official title: Determinants of Skin, Muscle and Bone Aging in HIV-1 Infected Patients
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.
- Conditions
- HIV-1-infection, Marker; Structural
- Being tested
- DXA (dual-energy x-ray absorptiometric) measurement
- Keywords
- Alterations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA (dual-energy x-ray absorptiometric) measurementProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | HIV-1 infected patients Receives: Procedure: DXA (dual-energy x-ray absorptiometric) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the earliest at the inclusion visit and within a 9-month window after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start3 May 2012
- Primary completion3 Jan 2013
- Study completion19 Dec 2013
Why it stopped: target number of patient not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick MERCIE, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067219
- Sponsor's protocol ID
- CHUBX 2011/02
- Acronym
- SIMBAD
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Skin, Muscle and Bone Aging in HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT04067219
- Acronym / sponsor ID
- SIMBAD / CHUBX 2011/02
- Conditions
- HIV-1-infection, Marker; Structural
- Keywords
- Alterations
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of patient not reached
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 May 2012 (actual)
- Primary completion
- 3 Jan 2013 (actual)
- Study completion
- 19 Dec 2013 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Procedure: DXA (dual-energy x-ray absorptiometric) measurementHIV-1 infected patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Hepatitis C virus co-infection
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXA (dual-energy x-ray absorptiometric) measurementDXA, 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). | Procedure or surgery | Single arm |
Primary outcome
Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters
Time frame: At the earliest at the inclusion visit and within a 9-month window after inclusion
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)
Results and safety
The study was stopped early (reason given: target number of patient not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick MERCIE, Pr principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
A study testing DXA (dual-energy x-ray absorptiometric) measurement in people with HIV-1-infection and Marker; Structural, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: target number of patient not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters (time frame: At the earliest at the inclusion visit and within a 9-month window after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.