The Microvascular Brain Retina And Kidney Study (MICROBREAK2)

August 8, 2018 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients

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 study and describe the CSVD in the HIV+ population by: (1) correlating the CSVD and the macro-vascular disease of the head and brain; (2) correlating the CSVD with the ocular (structural sentinel organ) and kidney (functional sentinel organ) micro-vascular disease.

HIV+/CSVD+ patients will have a complementary work-up with conventional MRI/MRA, thorough vascular explorations, and neurologic examination to evaluate the severity of the CSVD, the macro-vascular disease and the cerebral atrophy. They will have a full ophthalmic examination and specific kidney explorations to evaluate the micro-vascular disease of this two sentinel organs. The same number of HIV+/CSVD- matched patients will have the same work-up.

We are expecting to show the relationship between CSVD and cardiovascular risk factors in order to propose specific prevention. We will correlate the CSVD with the neurologic and cognitive function as it is already proved in the general population. We will correlate the CSVD with the ocular and kidney micro-vascular disease to propose fast, easy and cheap screening tools for the CSVD in the HIV+ population.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

163

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 With (patients) or without Cerebral Small Vessels Disease

Description

Inclusion Criteria:

  • age over 50 years old
  • chronic HIV seropositive patient infected for at least 5 years
  • antiretroviral therapy
  • plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year
  • cerebral small vessels disease (patients) or not (controls)

Exclusion Criteria:

  • Co-infection VHC
  • known antecedent of stroke
  • documented neurologic complication of HIV
  • drug user
  • glomerular filtration rate< 15 mL/mn
  • diabetic patient with kidney or retin complications
  • systolic blood pressure≥ 180 and/or diastolic blood pressure≥ 110 mmHg

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+ CSVD+
patients with HIV and cerebral small vessel disease
control HIV+ CSVD-
patients with HIV and without cerebral small vessel disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determinants of CSCV in patients with HIV
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2014

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (ESTIMATE)

August 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMR_2013-8

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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