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

NCT ID: NCT02852772

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-11-07

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.

Conditions

HIV

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PLHIV with microalbuminuria

Patient infected with HIV and well controlled by treatments, with microalbuminuria for at least 5 years

Cognitive function tests

Intervention Type: BEHAVIORAL

PLHIV without microalbuminuria (control)

Patient infected with HIV and well controlled by treatments, without microalbuminuria, matched for age +/- 5 years

Cognitive function tests

Intervention Type: BEHAVIORAL

Interventions

Cognitive function tests

Intervention Type: BEHAVIORAL

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

• Neurological disease found during the assessment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Countries

France

Other Identifiers

AMR_2014-2

Identifier Type: -

Identifier Source: org_study_id