Assessment of Age-related Hearing Loss in HIV-1 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-18

Study Completion Date

2019-02-26

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Seropositivity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy

No interventions assigned to this group

Control

non-HIV (matched for age and gender)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No