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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02082574
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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. 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.

Condition or disease
HIV Seropositivity

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Study Type : Observational
Actual Enrollment : 655 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1
Study Start Date : July 2013
Actual Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

HIV infected for more than 5 years, aged over 50, treated with ARV
non HIV (matched for age and gender)

Primary Outcome Measures :
  1. Cerebral small vessel disease [ Time Frame: baseline ]
    Cerebral small vessel disease detected with MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02082574

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Fondation Ophtalmologique Adolphe de Rothschild
Paris, Ile de France, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Principal Investigator: Antoine MOULIGNIER, Dr Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT02082574    
Other Study ID Numbers: AMR_2013-6
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases