Prevalence of Cerebral Small Vessel Disease in HIV Infected 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 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.

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Key information

Conditions

HIV Seropositivity Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

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
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)

Treatment and study plan

Primary outcomes

Cerebral small vessel disease

Time frame: baseline

Cerebral small vessel disease detected with MRI

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: MICROBREAK1

Important dates

Study start: 2013
Primary completion: 2016
First posted: Mar 10, 2014
Registry last updated: Oct 21, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed