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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.
The primary objective of this study is to analyze whether PLHIV initially aged between 55-70 years of age at baseline under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up in comparison with an age, gender and educational level matched HIV non-exposed control group from the CONSTANCES cohort.
The secondary objectives of this study are :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | 290 PLHIV, aged 55 to 76 years old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive functional assessment | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with cognitive decline | The global cognitive decline of patients, expressed through the mean Z-score (with higher scores indicating better cognition) using the mean of z scores of the 5 following cognitive tests (NPZ 5 score): Trail Making Test A-B (TMT A-B), Digit Symbol Substitution Task (DSST) of the WAIS-IV (Wechsler Adult Intelligence Scale), digital finger tapping test, word fluency and formal lexical and semantic evocation for language, Free and Cued Selective Reminding Test. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with NCI | Presence of neurocognitive impairment (NCI) according to the Frascati criteria and alternative classifications used to define HIV-Associated Neurocognitive Disorder (HAND) in PLHIV | 12 months |
| Description of the causes of NCI confirmed |
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Inclusion criteria
Inclusion criteria for PLHIV for the longitudinal study:
Inclusion criteria for PLHIV for the transversal study (only for new subjects):
Exclusion criteria
Non-inclusion criteria for PLHIV for both the longitudinal and transversal studies:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Makinson | Department of Infectious and Tropical Diseases, CHU Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin | Bordeaux | France | ||||
| Hôpital Saint André |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Prospective study, multicenter
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Description of the causes of NCI confirmed after a consensus reached by an expert panel group |
| 12 months |
| Incidence and prevalence of frailty | The Fried frailty score for the ancillary study on incidence and prevalence of frailty | 12 months |
| Bordeaux |
| France |
| CH Cannes | Cannes | France |
| CHD Vendée | La Roche-sur-Yon | France |
| CHU Grenoble Alpes | La Tronche | France |
| Hôpital Sainte Marguerite | Marseille | France |
| CHU Montpellier | Montpellier | France |
| CHU Nantes | Nantes | France |
| Hôpital Carémeau, CHU Nîmes | Nîmes | France |
| Hopital Pitié Salpêtrière | Paris | France |
| Hôpital Bretonneau, CHU Tours | Tours | France |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |