Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients (MICROBREAK1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Fondation Ophtalmologique Adolphe de Rothschild
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild Identifier:
First received: March 6, 2014
Last updated: May 12, 2016
Last verified: May 2016

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.

HIV Seropositivity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1

Resource links provided by NLM:

Further study details as provided by Fondation Ophtalmologique Adolphe de Rothschild:

Primary Outcome Measures:
  • Cerebral small vessel disease [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Cerebral small vessel disease detected with MRI

Estimated Enrollment: 750
Study Start Date: July 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
HIV infected for more than 5 years, aged over 50, treated with ARV
non HIV (matched for age and gender)


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV patients over 50 years old, infected for at least 5 years, treated with antiretroviral (ARV) therapy

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02082574

Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, Ile de France, France, 75019
Contact: Anoine MOULIGNIER, Dr    +33 148 036 778   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Principal Investigator: Antoine MOULIGNIER, Dr Fondation Ophtalmologique Adolphe de Rothschild
  More Information

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT02082574     History of Changes
Other Study ID Numbers: AMR_2013-6 
Study First Received: March 6, 2014
Last Updated: May 12, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Cerebral Small Vessel Diseases
HIV Seropositivity
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Nervous System Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Vascular Diseases
Virus Diseases processed this record on May 30, 2016