HIV Seropositivity Clinical Trial
— HELOOfficial title:
Assessment of Age-related Hearing Loss in HIV-1 Patients
Verified date | September 2020 |
Source | Fondation Ophtalmologique Adolphe de Rothschild |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 206 |
Est. completion date | February 26, 2019 |
Est. primary completion date | February 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
France | Fondation Ophtalmologique Adolphe de Rothschild | Paris | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hearing loss at several frequencies | Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB. | Baseline | |
Secondary | threshold for speech intelligibility | measured by speech audiometry | Baseline | |
Secondary | Proportion of patients with neuropathic hearing loss | Baseline | ||
Secondary | Interval I-V on the evoked-response audiogram | Baseline | ||
Secondary | Maximum speech intelligibility | Measured by speech audiometry | Baseline | |
Secondary | Proportion of patients with age-related hearing loss | Baseline |
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