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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fondation Ophtalmologique Adolphe de Rothschild
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT02082574
First received: March 6, 2014
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition
HIV Seropositivity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1

Resource links provided by NLM:


Further study details as provided by Fondation Ophtalmologique Adolphe de Rothschild:

Primary Outcome Measures:
  • Cerebral small vessel disease [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Cerebral small vessel disease detected with MRI


Estimated Enrollment: 750
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients
HIV infected for more than 5 years, aged over 50, treated with ARV
control
non HIV (matched for age and gender)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082574

Locations
France
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, Ile de France, France, 75019
Contact: Anoine MOULIGNIER, Dr    +33 148 036 778    amoulignier@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Antoine MOULIGNIER, Dr Fondation Ophtalmologique Adolphe de Rothschild
  More Information

No publications provided

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02082574     History of Changes
Other Study ID Numbers: AMR_2013-6
Study First Received: March 6, 2014
Last Updated: August 5, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
HIV Seropositivity
Cerebral Small Vessel Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014