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

NCT02852772 | Completed

• 1 other identifier: AMR_2014-2
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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

Keywords

Cognitive impairment; HIV; Microalbuminuria; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PLHIV with microalbuminuria

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

Behavioral: Cognitive function tests

PLHIV without microalbuminuria (control)

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

Behavioral: Cognitive function tests

Interventions

Cognitive function tests BEHAVIORAL

PLHIV with microalbuminuria; PLHIV without microalbuminuria (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered in the HIVREINE database (which combines nephrology and infectious diseases services of AP-HP, Greater Paris University Hospitals)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2014
• Primary Completion: November 7, 2016
• Study Completion: November 7, 2016
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

FR (1)