Does Micro-albuminuria is a Predictive Factor for Cognitive Impairment in Persons Living With HIV (PLHIV) Who Achieve cART-sustained Immunovirological Control ?

Completed

• Conditions: HIV
• Interventions: Behavioral: Cognitive function tests

• Registration Number: NCT02852772
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2016-11-07
• Study Completion: 2016-11-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PLHIV with microalbuminuria	Cognitive function tests	Patient infected with HIV and well controlled by treatments, with microalbuminuria for at least 5 years
PLHIV without microalbuminuria (control)	Cognitive function tests	Patient infected with HIV and well controlled by treatments, without microalbuminuria, matched for age +/- 5 years

Primary Outcome Measures

Name	Time	Method
Z-Score of five neurocognitive domains tested and global deficit score	4 hours	Comparisons of composite cognitive scores (z-score) and scores of global cognitive deficits (GDS) between the two populations. The neuropsychological tests are made during a single consultation of a half day.

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France