Prevalence of Cerebral Small Vessel Disease in HIV Infected Patients

NCT02082574 | Completed DMC

• 1 other identifier: AMR_2013-6
• Study Type: observational
• Target: 655
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Seropositivity

Outcome Measures

Primary Outcomes (1)

• Cerebral small vessel disease

  Cerebral small vessel disease detected with MRI

  baseline

Study Arms (2)

patients

HIV infected for more than 5 years, aged over 50, treated with ARV

control

non HIV (matched for age and gender)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

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

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Antoine MOULIGNIER, Dr

  Fondation Ophtalmologique Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: July 1, 2013
• Primary Completion: June 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-07

Locations

FR (1)