HIV SeropositivityHELONCT02154971
Assessment of Age-related Hearing Loss in HIV-1 Patients
An observational study of HIV Seropositivity, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The ageing process is known to be accelerated in HIV-infected patients, compared to the general population. Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than 70% of people above 65 years. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HIV Seropositivity
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2013to 26 Feb 2019
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed for HIV infection in the department of infectious diseases of Saint-Antoine hospital or Bichat hospital and/or by a private HIV-specialized physician in Paris, France
Who may be able to join
- Age 40 years and more
- HIV-1 infection known since 10 years and more
- Undetectable plasmatic HIV-1 viral load thanks to antiretroviral therapy (any regimen) for at least 5 years
- CD4 lymphocytes count above 350
- Condition of Cerebral Small Vessel Disease detected recently with MRI
Who cannot join
- Personal history of otologic pathology or otologic surgery
- Family history of hearing impairment
- Personal history of bacterial meningitis
- Personal history of neurological disease
- Personal history of treatment with ototoxic drugs
- Personal history of treatment with chemotherapy
Show all 13Show fewer
- Use of illegal drugs (except cannabis or poppers)
- Alcoholism
- Diabetes complicated by retinopathy and/or by glomerular filtration rate < 60 mL/min and/or by proteinuria > 300 mg)
- Uncontrolled high blood pressure (WHO criteria)
- MRI contraindication
- Known pregnancy or breastfeeding woman
- No medical insurance coverage
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
The ageing process is known to be accelerated in HIV-infected patients, compared to the general population.
Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than 70% of people above 65 years. It is believed to be mostly the consequence of a mitochondrial damage caused by oxidative stress.
Read more
Risk factors for accelerated age-related hearing loss are present in many HIV-infected patients : chronic inflammation, smoking, diabetes, etc.
The global aim is to measure the prevalence of presbyacusia in a well controlled HIV positive population in France, and to compare it to HIV negative controls matched for age and sex.
90 HIV positive patients and 90 age- and sex- matched HIV negative controls will undergo a screening for presbyacusia (pure-tone, speech and evoked-response audiometry).
We expect to find an increased prevalence of presbyacusia in HIV-infected patients, as compared to controls matched for age and sex.
- Conditions
- HIV Seropositivity
- Keywords
- HIV Seropositivity, Audiometry, Hearing Loss
- Medical subject headings
- HIV Seropositivity, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy | |
| Control | non-HIV (matched for age and gender) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing loss at several frequencies
Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.
Measured: Baseline
Secondary outcomes (5)
threshold for speech intelligibility
measured by speech audiometry
Measured: Baseline
Proportion of patients with neuropathic hearing loss
Measured: Baseline
Interval I-V on the evoked-response audiogram
Measured: Baseline
Maximum speech intelligibility
Measured by speech audiometry
Measured: Baseline
Proportion of patients with age-related hearing loss
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start18 Nov 2013
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Antoine Moulignier, MD, Principal investigator, Fondation Ophtalmologique Antoine de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154971
- Sponsor's protocol ID
- AMR_2013-10
- Acronym
- HELO
- Status last verified
- Sep 2020
- First submitted
- 2 Jun 2014
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Age-related Hearing Loss in HIV-1 Patients
- ClinicalTrials.gov ID
- NCT02154971
- Acronym / sponsor ID
- HELO / AMR_2013-10
- Conditions
- HIV Seropositivity
- Keywords
- HIV Seropositivity, Audiometry, Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 18 Nov 2013 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 4 Jun 2014 (estimated)
- 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 ageing process is known to be accelerated in HIV-infected patients, compared to the general population.
Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than 70% of people above 65 years. It is believed to be mostly the consequence of a mitochondrial damage caused by oxidative stress.
Risk factors for accelerated age-related hearing loss are present in many HIV-infected patients : chronic inflammation, smoking, diabetes, etc.
The global aim is to measure the prevalence of presbyacusia in a well controlled HIV positive population in France, and to compare it to HIV negative controls matched for age and sex.
90 HIV positive patients and 90 age- and sex- matched HIV negative controls will undergo a screening for presbyacusia (pure-tone, speech and evoked-response audiometry).
We expect to find an increased prevalence of presbyacusia in HIV-infected patients, as compared to controls matched for age and sex.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy |
| Control | – | –non-HIV (matched for age and gender) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed for HIV infection in the department of infectious diseases of Saint-Antoine hospital or Bichat hospital and/or by a private HIV-specialized physician in Paris, France
Key inclusion criteria (5 listed)
- Age 40 years and more
- HIV-1 infection known since 10 years and more
- Undetectable plasmatic HIV-1 viral load thanks to antiretroviral therapy (any regimen) for at least 5 years
- CD4 lymphocytes count above 350
- Condition of Cerebral Small Vessel Disease detected recently with MRI
Key exclusion criteria (13 listed)
- Personal history of otologic pathology or otologic surgery
- Family history of hearing impairment
- Personal history of bacterial meningitis
- Personal history of neurological disease
- Personal history of treatment with ototoxic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hearing loss at several frequencies
Time frame: Baseline
Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.
5 secondary outcomes
threshold for speech intelligibility
Time frame: Baseline
Proportion of patients with neuropathic hearing loss
Time frame: Baseline
Interval I-V on the evoked-response audiogram
Time frame: Baseline
Maximum speech intelligibility
Time frame: Baseline
Proportion of patients with age-related hearing loss
Time frame: Baseline
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 16 Sep 2020.
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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.
Antoine Moulignier, MD principal investigator
Fondation Ophtalmologique Antoine de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 5 inclusion and 13 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
hearing loss at several frequencies (time frame: Baseline). 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 16 Sep 2020.