Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients

HIV Seropositivity Clinical Trial

— MICROBREAK1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082574
• Other study ID #: AMR_2013-6
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: October 20, 2016
• Start date: July 2013

Study information

• Verified date: July 2016
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• HIV Seropositivity

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral small vessel disease	Cerebral small vessel disease detected with MRI	baseline	No