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

July 26, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

November 7, 2016

Study Completion (ACTUAL)

November 7, 2016

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (ESTIMATE)

August 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMR_2014-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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