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OpenTrials
Completed

NCT Number: NCT03268109

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

assessment of cognitive impairment

Other

Measure of Global Deficit Score

Primary outcomes

  1. cognitive impairment

    Time frame: baseline

    cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.

Acronym: COGITO

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 31, 2017
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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