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

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.

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Key information

Conditions

HIV Chronic Disease Cognition Disorders Cognitive Dysfunction Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive function tests

Behavioral

Primary outcomes

Z-Score of five neurocognitive domains tested and global deficit score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: ALCOVE

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Aug 2, 2016
Registry last updated: Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed