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COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old (COGITO)

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ClinicalTrials.gov Identifier: NCT03268109
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to quantify for planning early intervention to attenuate both functional and occupational disabilities due to cognitive impairment.

Condition or disease Intervention/treatment
Memory Impairment HIV/AIDS Cognitive Impairment Other: assessment of cognitive impairment

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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : September 22, 2019
Estimated Study Completion Date : September 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
people living with HIV
subjects infected with HIV and with cognitive complaints
Other: assessment of cognitive impairment
Measure of Global Deficit Score

control subjects
subjects not infected with HIV and with cognitive complaints
Other: assessment of cognitive impairment
Measure of Global Deficit Score




Primary Outcome Measures :
  1. cognitive impairment [ Time Frame: baseline ]
    cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cART-treated PLHIV ≥65 years old having a memory complaint and virologically controlled for at least 1 year and to compare PLHIV to HIV-uninfected individuals matched for age, sex and educational level
Criteria

Inclusion Criteria:

  • Personal or familial cognitive complaints
  • Individual aged ≥ 65 years old and < 81 years old
  • Instrumental activities of daily living (IADL) score between 3-4
  • French speaking individual
  • Informed consent signed For PLHIV
  • HIV infection
  • Undetectable HIV viral load ≥ 1 year
  • Current cluster of differentiation (CD4) cell count > 100/mm3 For controls
  • negative HIV serology ≤ 6 months

Exclusion Criteria:

  • Opportunistic infection < 5 years
  • Contraindications to MRI

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): NCT03268109


Contacts
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Contact: Laurence Salomon, MD, PhD 0033148036431 lsalomon@for.paris
Contact: Lucia Lopes llopes@for.paris

Locations
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France
Fondation Ophtalmologique A. de Rothschild /URC Recruiting
Paris, France, 75019
Contact: Fondation Ophtalmologique A. de R /URC    148036433      
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Antoine Moulignier, MD Fondation Ophtalmologique A. de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03268109     History of Changes
Other Study ID Numbers: AMR_2017_3
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders