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Clinical Trials/NCT02082574
NCT02082574
Completed
Not Applicable

Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1

Fondation Ophtalmologique Adolphe de Rothschild1 site in 1 country655 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Seropositivity
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Enrollment
655
Locations
1
Primary Endpoint
Cerebral small vessel disease
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
June 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Cerebral small vessel disease

Time Frame: baseline

Cerebral small vessel disease detected with MRI

Study Sites (1)

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