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

October 20, 2016 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

655

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral small vessel disease
Time Frame: baseline
Cerebral small vessel disease detected with MRI
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Antoine MOULIGNIER, Dr, Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (ESTIMATE)

March 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMR_2013-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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