Clinical trial NCT02210130: The Microvascular Brain Retina And Kidney Study
Official title: Measure of Specific Determinants of the Cerebral Small Vessel Disease in HIV+ Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Small Vessels Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: French National Agency for Research on AIDS and Viral Hepatitis
First posted: 2014-08-06
Enrollment: 163
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: determinants of CSCV in patients with HIV
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
state: Ile De France
Study officials:
References:
citation: Januel E, Godin O, Moulignier A, Lescure FX, Savatovsky J, Lamirel C, Valin N, Tubiana R, Canestri A, Roux P, Sadik JC, Salomon L, Katlama C, Yazdanpanah Y, Pialoux G, Girard PM, Costagliola D, Assoumou L; Microvascular Brain Retina And Kidney (MicroBREAK) Study Group. Brief Report: Impact of ART Classes on the Increasing Risk of Cerebral Small-Vessel Disease in Middle-Aged, Well-Controlled, cART-Treated, HIV-Infected Individuals. J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):547-551. doi: 10.1097/QAI.0000000000002084.