Clinical trial NCT02852772: Does Micro-albuminuria is a Predictive Factor for Cognitive Impairment in Persons Living With HIV (PLHIV) Who Achieve cART-sustained Immunovirological Control ?
Official title: Does Micro-albuminuria is a Predictive Factor for Cognitive Impairment in Persons Living With HIV (PLHIV) Who Achieve cART-sustained Immunovirological Control ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Cognitive impairment
HIV
Microalbuminuria
Chronic kidney disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered in the HIVREINE database (which combines nephrology and infectious diseases services of AP-HP, Greater Paris University Hospitals)

Brief summary: Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment. Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably affecting the small vessels. In the older general population microalbuminuria is associated with greater annual cognitive decline and has been proposed as an easily and inexpensive measured marker predicting future cognitive function decline. Ageing of the PLH leads to an increase of cognitive disorders and chronic renal failure incidence and could imply a common underlying mechanism affecting the renal and cerebral microvasculature. In this setting the investigators undertake this prospective, cross-sectional, case-control study to determine whether the presence of a microalbuminuria at least 5 years ago in PLHs with sustained good combination antiretroviral therapy (cART)-controlled immunovirological parameters could be a marker predicting future cognitive impairment. They chose PLHs infected for at least 5 years and with cART-sustained immunovirological control for at least 1 year.


Eligibility criteria: Inclusion Criteria:

* Known HIV infection for at least 5 years
* Undetectable viral load under antiretroviral (ARV) treatment for at least 1 year, regardless of the type of ARV
* Number of CD4 ≥ 350, regardless of the CD4 nadir
* Unopposed to participate to the study

For cases

- Micro-albuminuria defined by microalbuminuria / creatinuria between 3 and 30 mg/mmol

For controls, matched for age +/- 5 years - Absence of microalbuminuria defined by microalbuminuria / creatinuria \<3 mg/mmol

Exclusion criteria

* Known neurological disease, active or former
* Active and regular use of drugs
* Active Chronic alcoholism
* Diabetes with known complications
* Renal failure with glomerular filtration rate \<15 ml / min
* Micro-albuminuria / creatinuria\> 30 mg / mmol
* HIVAN
* Unbalanced arterial hypertension
* Patient did not have dosing glucose and lipid levels in over a year
* Unaffiliated patient (or copyright holder) to a social security scheme
* People enjoying a measure of legal protection Pregnant or breastfeeding

Secondary exclusion criteria

- Neurological disease found during the assessment.

Primary outcomes:
measure: Z-Score of five neurocognitive domains tested and global deficit score
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References: