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NCT05385588Completed

Aging With HIV and Neurocognitive Decline, a Follow-up Study

Source: ClinicalTrials.gov · Last updated 30 Jan 2025

Brief summary (registry, in English)

The ANRS ( Agence Nationale de Recherches sur le Sida et les Hépatites virales) 0093s Aging HAND study is to assess whether PLHIV (People Living with HIV) initially between 55-70 years of age at baseline analysis under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up. Aging HAND is a French, multicentric, longitudinal, transversal, prospective study with inclusion of 290 PLHIV.

Status (registry)
Completed
Study type
Interventional
Enrollment
282 (actual)
First submitted
18 May 2022
Start date
14 Nov 2022
Primary completion date
1 Feb 2024
Lead sponsor
ANRS, Emerging Infectious Diseases
Diseases
HIV
NCT number
NCT05385588

What you commit to

  • Study type: Interventional
  • Participants enrolled: 282
  • From 14 Nov 2022 to the primary completion date, 1 Feb 2024
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • With recent extensive neurocognitive evaluation within 6 months prior to inclusion

Other illness

  • An Isolated HIV-2 infection
  • Confused or with an ongoing neurological disease
  • Presenting psychiatric syndromes interfering with cognitive evaluation;
  • With neurological disease with ongoing clinically relevant sequela

Other

  • Non-inclusion criteria for PLHIV for both the longitudinal and transversal studies:
  • With sensorial loss, analphabetism or language barriers rendering the interpretation of tests difficult.
  • Participating in another research program, prohibiting the participating in additional research
  • Vulnerable: minors, under guardianship or curatorship, or persons deprived of liberty for administrative or judiciary reasons

Who the study is looking for

  • Having participated in the ANRS EP58 HAND 55-70 study
  • A signed informed consent
  • To be affiliated and benefit from the French Social Security
  • HIV-1
  • Aged between 55 years and 76 years;
  • with a viral load \< 50 copies/mL for more than 24 months (with a minimum of 3 available viral loads 6 months prior to inclusion). Blips -defined by a transient increase in viral load- are allowed if \< 200 copies/mL, with a maximum of two blips within 24 months;
  • With a CD4 (cluster of differentiation 4) count at inclusion ≥ 200 cells/µL for more than the last 12 months (with a last available CD4 count \< 6 months of inclusion);
  • A signed informed consent
  • To be affiliated and benefit from the French Social Security

Age in the registry: 55 years to 76 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hopital Pellegrin
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BordeauxFranceUnknown status
Hôpital Saint-André
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BordeauxFranceUnknown status
CH Cannes
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CannesFranceUnknown status
CHD Vendée
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La Roche-sur-YonFranceUnknown status
Chu Grenoble Alpes
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La TroncheFranceUnknown status
Hopital Sainte-Marguerite
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MarseilleFranceUnknown status
CHU Montpellier
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MontpellierFranceUnknown status
CHU Nantes
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NantesFranceUnknown status
Hôpital Carémeau, CHU Nîmes
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NîmesFranceUnknown status
Hopital Pitie-Salpetriere
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ParisFranceUnknown status
Hôpital Bretonneau-CHU Tours
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ToursFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.