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

HIV Clinical Trial

— ALCOVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852772
• Other study ID #: AMR_2014-2
• Status: Completed
• Phase: N/A
• First received: July 26, 2016
• Last updated: July 26, 2017
• Start date: July 2014
• Est. completion date: November 7, 2016

Study information

• Verified date: July 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 7, 2016
• Est. primary completion date: November 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Albuminuria
• Cognition Disorders
• HIV

Intervention

Behavioral:
• Cognitive function tests

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Z-Score of five neurocognitive domains tested and global deficit score	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.	4 hours