HIV InfectionsAgingHANDNCT05385588
Aging With HIV and Neurocognitive Decline, a Follow-up Study
A study testing cognitive functional assessment in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 11 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 to 76 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- cognitive functional assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 11 sitesFrance
- Study dates
- 14 Nov 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having participated in the ANRS EP58 HAND 55-70 study
- A signed informed consent
- To be affiliated and benefit from the French Social Security
- Inclusion criteria for PLHIV for the transversal study (only for new subjects):
- HIV-1
- Aged between 55 years and 76 years;
Show all 10Show fewer
- 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
Who cannot join
- Non-inclusion criteria for PLHIV for both the longitudinal and transversal studies:
- An Isolated HIV-2 infection
- Confused or with an ongoing neurological disease
- Presenting psychiatric syndromes interfering with cognitive evaluation;
- With sensorial loss, analphabetism or language barriers rendering the interpretation of tests difficult.
- With recent extensive neurocognitive evaluation within 6 months prior to inclusion
Show all 9Show fewer
- With neurological disease with ongoing clinically relevant sequela
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hôpital Pellegrin
Bordeaux
Hôpital Saint André
Bordeaux
CH Cannes
Cannes
CHD Vendée
La Roche-sur-Yon
CHU Grenoble Alpes
La Tronche
Hôpital Sainte Marguerite
Marseille
CHU Montpellier
Montpellier
CHU Nantes
Nantes
Hôpital Carémeau, CHU Nîmes
Nîmes
Hopital Pitié Salpêtrière
Paris
Hôpital Bretonneau, CHU Tours
Tours
About this study
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.
Read the detailed description
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 :
- To determine the prevalence of neurocognitive impairment (NCI) according to the Frascati criteria, clinical consensus and alternative classifications, after additional accrual of individuals aged 55 to 76 years for a more precise and extensive age range analysis of NCI
- To describe the incidence and prevalence of the frailty syndromes, and their relation with co-morbidities and NCI, using the Fried score as a measure of frailty
- To constitute a plasma and serum biobank for biomarkers study related to the aging of PLHIV
- Conditions
- HIV Infections
- Being tested
- cognitive functional assessment
- Keywords
- HIV, aging, neurocognitive decline, frailty syndromes
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive functional assessmentOther
- Self-administered questionnaire
- Cognitive and functional tests
- Medical questionnaire
- Sampling for biobank (28-32 ml will be collected)
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | 290 PLHIV, aged 55 to 76 years old Receives: Other: cognitive functional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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
Measured: 12 months
Description of the causes of NCI confirmed
Description of the causes of NCI confirmed after a consensus reached by an expert panel group
Measured: 12 months
Incidence and prevalence of frailty
The Fried frailty score for the ancillary study on incidence and prevalence of frailty
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start14 Nov 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective study, multicenter
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alain Makinson, Principal investigator, Department of Infectious and Tropical Diseases, CHU Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385588
- Sponsor's protocol ID
- ANRS 0093s Aging HAND
- Acronym
- AgingHAND
- Status last verified
- Jan 2025
- First submitted
- 18 May 2022
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging With HIV and Neurocognitive Decline, a Follow-up Study
- ClinicalTrials.gov ID
- NCT05385588
- Acronym / sponsor ID
- AgingHAND / ANRS 0093s Aging HAND
- Conditions
- HIV Infections
- Keywords
- HIV, aging, neurocognitive decline, frailty syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 :
- To determine the prevalence of neurocognitive impairment (NCI) according to the Frascati criteria, clinical consensus and alternative classifications, after additional accrual of individuals aged 55 to 76 years for a more precise and extensive age range analysis of NCI
- To describe the incidence and prevalence of the frailty syndromes, and their relation with co-morbidities and NCI, using the Fried score as a measure of frailty
- To constitute a plasma and serum biobank for biomarkers study related to the aging of PLHIV
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study, multicenter
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: cognitive functional assessment290 PLHIV, aged 55 to 76 years old |
Who may qualify
- Ages
- 55 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- An Isolated HIV-2 infection
- Confused or with an ongoing neurological disease
- Presenting psychiatric syndromes interfering with cognitive evaluation;
- With sensorial loss, analphabetism or language barriers rendering the interpretation of tests difficult.
- With recent extensive neurocognitive evaluation within 6 months prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive functional assessment* Self-administered questionnaire * Cognitive and functional tests * Medical questionnaire * Sampling for biobank (28-32 ml will be collected) | Other | Single arm |
Primary outcome
Proportion of patients with cognitive decline
Time frame: 12 months
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.
3 secondary outcomes
Proportion of patients with NCI
Time frame: 12 months
Description of the causes of NCI confirmed
Time frame: 12 months
Incidence and prevalence of frailty
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Makinson principal investigator
Department of Infectious and Tropical Diseases, CHU Montpellier
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive functional assessment in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with cognitive decline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.