Cerebral Small Vessels DiseaseMICROBREAK2NCT02210130
The Microvascular Brain Retina And Kidney Study
An observational study of Cerebral Small Vessels Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cerebral Small Vessels Disease
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Apr 2017
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV patients over 50 years old, infected for at least 5 years, treated with antiretroviral (ARV) therapy With (patients) or without Cerebral Small Vessels Disease
Who may be able to join
- age over 50 years old
- chronic HIV seropositive patient infected for at least 5 years
- antiretroviral therapy
- plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year
- cerebral small vessels disease (patients) or not (controls)
Who cannot join
- Co-infection VHC
- known antecedent of stroke
- documented neurologic complication of HIV
- drug user
- glomerular filtration rate< 15 mL/mn
- diabetic patient with kidney or retin complications
- systolic blood pressure≥ 180 and/or diastolic blood pressure≥ 110 mmHg
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Official title: Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients
Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. CSVD is directly correlated with age and cardiovascular risk factors and therefore would be challenging in term of public health care in the future. While HIV patients share the same cardiovascular risk factors and they are often diagnosed with cognitive impairment and frailty, CSVD has not been yet described in this population.
The global aim is to study and describe the CSVD in the HIV+ population by: (1) correlating the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular disease.
Read more
HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel organs. The same number of HIV+/CSVD- matched patients will have the same work-up.
We are expecting to show the relationship between CSVD and cardiovascular risk factors in order to propose specific prevention. We will correlate the CSVD with the neurologic and cognitive function as it is already proved in the general population. We will correlate the CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap screening tools for the CSVD in the HIV+ population.
- Conditions
- Cerebral Small Vessels Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients HIV+ CSVD+ | patients with HIV and cerebral small vessel disease | |
| control HIV+ CSVD- | patients with HIV and without cerebral small vessel disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
determinants of CSCV in patients with HIV
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessels DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- French National Agency for Research on AIDS and Viral Hepatitis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210130
- Sponsor's protocol ID
- AMR_2013-8
- Acronym
- MICROBREAK2
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2014
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Januel E, Godin O, Moulignier A, Lescure FX, Savatovsky J, Lamirel C, Valin N, Tubiana R, Canestri A, Roux P, Sadik JC, Salomon L, Katlama C, Yazdanpanah Y, Pialoux G, Girard PM, Costagliola D, Assoumou L; Microvascular Brain Retina And Kidney (MicroBREAK) Study Group. Brief Report: Impact of ART Classes on the Increasing Risk of Cerebral Small-Vessel Disease in Middle-Aged, Well-Controlled, cART-Treated, HIV-Infected Individuals. J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):547-551. doi: 10.1097/QAI.0000000000002084.
PubMed 31107300
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients
- ClinicalTrials.gov ID
- NCT02210130
- Acronym / sponsor ID
- MICROBREAK2 / AMR_2013-8
- Conditions
- Cerebral Small Vessels Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- French National Agency for Research on AIDS and Viral Hepatitis
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 6 Aug 2014 (estimated)
- 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.
Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. CSVD is directly correlated with age and cardiovascular risk factors and therefore would be challenging in term of public health care in the future. While HIV patients share the same cardiovascular risk factors and they are often diagnosed with cognitive impairment and frailty, CSVD has not been yet described in this population.
The global aim is to study and describe the CSVD in the HIV+ population by: (1) correlating the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular disease.
HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel organs. The same number of HIV+/CSVD- matched patients will have the same work-up.
We are expecting to show the relationship between CSVD and cardiovascular risk factors in order to propose specific prevention. We will correlate the CSVD with the neurologic and cognitive function as it is already proved in the general population. We will correlate the CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap screening tools for the CSVD in the HIV+ population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients HIV+ CSVD+ | – | –patients with HIV and cerebral small vessel disease |
| control HIV+ CSVD- | – | –patients with HIV and without cerebral small vessel disease |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients over 50 years old, infected for at least 5 years, treated with antiretroviral (ARV) therapy With (patients) or without Cerebral Small Vessels Disease
Key inclusion criteria (5 listed)
- age over 50 years old
- chronic HIV seropositive patient infected for at least 5 years
- antiretroviral therapy
- plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year
- cerebral small vessels disease (patients) or not (controls)
Key exclusion criteria (7 listed)
- Co-infection VHC
- known antecedent of stroke
- documented neurologic complication of HIV
- drug user
- glomerular filtration rate< 15 mL/mn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
determinants of CSCV in patients with HIV
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Results publication: PubMed 31107300Januel E, Godin O, Moulignier A, Lescure FX, Savatovsky J, Lamirel C, Valin N, Tubiana R, Canestri A, Roux P, Sadik JC, Salomon L, Katlama C, Yazdanpanah Y, Pialoux G, Girard PM, Costagliola D, Assoumou L; Microvascular Brain Retina And Kidney (MicroBREAK) Study Group. Brief Report: Impact of ART Classes on the Increasing Risk of Cerebral Small-Vessel Disease in Middle-Aged, Well-Controlled, cART-Treated, HIV-Infected Individuals. J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):547-551. doi: 10.1097/QAI.0000000000002084.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessels Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
determinants of CSCV in patients with HIV (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02210130, which also lists 1 linked publication.
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 2 Jul 2026.