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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02852772

Acronym

ALCOVE

Enrollment

Registered

2016-08-02

Start date

2014-07-31

Completion date

2016-11-07

Last updated

2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Cognitive impairment, HIV, Microalbuminuria, Chronic kidney disease

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.

Interventions

BEHAVIORALCognitive function tests

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026