HIV SeropositivityMICROBREAK1NCT02082574
Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients
An observational study of HIV Seropositivity, 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
- HIV Seropositivity
- How many people
- 655 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jun 2016
- 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
Who may be able to join
- age over 50
- chronic HIV seropositive patient infected for at least 5 years
- treated with any antiretroviral (ARV) therapy
- plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year
Who cannot join
- co-infection with hepatitis C virus (HCV)
- uncontrolled high blood pressure (WHO criteria)
- Personal history of cerebral infarction or cerebral ischemia
- Personal history of neurological complication of the HIV-infection
- Use of illegal drugs (except cannabis or poppers)
- Glomerular filtration rate < 15 mL/mn
- Complicated diabetes mellitus (glomerular filtration rate < 60ml/mn and/or proteinuria> 300 mg and/or retinopathy)
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: Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1
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 compare the prevalence of CSVD in a well controlled HIV+ population compared to HIV- controls matched with age and sex.
Read more
500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD with a 10 minutes MRI (FLAIR and T2*).
Prevalence of the CSVD will be compared between HIV+ patients and controls. General and HIV-specific parameters from their electronic medical records will be compared between HIV+/CSVD+ and HIV+/CSVD- patients.
We are expecting to prove that CSVD is more frequent in HIV+ population.
- Conditions
- HIV Seropositivity
- Medical subject headings
- HIV Seropositivity
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 infected for more than 5 years, aged over 50, treated with ARV | |
| control | non HIV (matched for age and gender) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral small vessel disease
Cerebral small vessel disease detected with MRI
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Antoine MOULIGNIER, Dr, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082574
- Sponsor's protocol ID
- AMR_2013-6
- Acronym
- MICROBREAK1
- Status last verified
- Jul 2016
- First submitted
- 6 Mar 2014
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1
- ClinicalTrials.gov ID
- NCT02082574
- Acronym / sponsor ID
- MICROBREAK1 / AMR_2013-6
- Conditions
- HIV Seropositivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (actual)
- First posted
- 10 Mar 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 compare the prevalence of CSVD in a well controlled HIV+ population compared to HIV- controls matched with age and sex.
500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD with a 10 minutes MRI (FLAIR and T2*).
Prevalence of the CSVD will be compared between HIV+ patients and controls. General and HIV-specific parameters from their electronic medical records will be compared between HIV+/CSVD+ and HIV+/CSVD- patients.
We are expecting to prove that CSVD is more frequent in HIV+ population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –HIV infected for more than 5 years, aged over 50, treated with ARV |
| control | – | –non HIV (matched for age and gender) |
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
Key inclusion criteria (4 listed)
- age over 50
- chronic HIV seropositive patient infected for at least 5 years
- treated with any antiretroviral (ARV) therapy
- plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year
Key exclusion criteria (7 listed)
- co-infection with hepatitis C virus (HCV)
- uncontrolled high blood pressure (WHO criteria)
- Personal history of cerebral infarction or cerebral ischemia
- Personal history of neurological complication of the HIV-infection
- Use of illegal drugs (except cannabis or poppers)
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
Cerebral small vessel disease
Time frame: baseline
Cerebral small vessel disease detected with MRI
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 21 Oct 2016.
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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.
Antoine MOULIGNIER, Dr principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
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 HIV Seropositivity, 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 4 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 21 Oct 2016. 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?
Cerebral small vessel disease (time frame: baseline). 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 21 Oct 2016.