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

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ClinicalTrials.gov Identifier: NCT02852772
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.

Condition or disease Intervention/treatment
HIV Behavioral: Cognitive function tests

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Does Micro-albuminuria is a Predictive Factor for Cognitive Impairment in Persons Living With HIV (PLHIV) Who Achieve cART-sustained Immunovirological Control ?
Study Start Date : July 2014
Actual Primary Completion Date : November 7, 2016
Actual Study Completion Date : November 7, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Secondary exclusion criteria

- Neurological disease found during the assessment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852772


Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02852772    
Other Study ID Numbers: AMR_2014-2
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Cognitive impairment
HIV
Microalbuminuria
Chronic kidney disease
Additional relevant MeSH terms:
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Albuminuria
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms