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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fondation Ophtalmologique Adolphe de Rothschild
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT02082574
First received: March 6, 2014
Last updated: August 5, 2014
Last verified: August 2014

March 6, 2014
August 5, 2014
July 2013
December 2014   (final data collection date for primary outcome measure)
Cerebral small vessel disease [ Time Frame: baseline ] [ Designated as safety issue: No ]
Cerebral small vessel disease detected with MRI
Same as current
Complete list of historical versions of study NCT02082574 on ClinicalTrials.gov Archive Site
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Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients
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.

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

HIV patients over 50 years old, infected for at least 5 years, treated with antiretroviral (ARV) therapy

HIV Seropositivity
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  • patients
    HIV infected for more than 5 years, aged over 50, treated with ARV
  • control
    non HIV (matched for age and gender)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
50 Years and older
No
France
 
NCT02082574
AMR_2013-6
Yes
Fondation Ophtalmologique Adolphe de Rothschild
Fondation Ophtalmologique Adolphe de Rothschild
Not Provided
Principal Investigator: Antoine MOULIGNIER, Dr Fondation Ophtalmologique Adolphe de Rothschild
Fondation Ophtalmologique Adolphe de Rothschild
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP