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OpenTrials
Completed

NCT Number: NCT02210130

The Microvascular Brain Retina And Kidney Study

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. determinants of CSCV in patients with HIV

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

  • French National Agency for Research on AIDS and Viral Hepatitis

Registry information

Official study title

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

Acronym: MICROBREAK2

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Aug 6, 2014
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.