Clinical trial NCT02154971: Assessment of Age-related Hearing Loss in HIV-1 Patients
Official title: Assessment of Age-related Hearing Loss in HIV-1 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Seropositivity
Keywords: HIV Seropositivity
Audiometry
Hearing Loss
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2014-06-04
Enrollment: 206
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: hearing loss at several frequencies
timeFrame: Baseline
Secondary outcomes:
measure: threshold for speech intelligibility
timeFrame: Baseline
measure: Proportion of patients with neuropathic hearing loss
timeFrame: Baseline
measure: Interval I-V on the evoked-response audiogram
timeFrame: Baseline
measure: Maximum speech intelligibility
timeFrame: Baseline
measure: Proportion of patients with age-related hearing loss
timeFrame: Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
state: Ile De France
Study officials:
affiliation: Fondation Ophtalmologique Antoine de Rothschild
name: Antoine Moulignier, MD
role: PRINCIPAL_INVESTIGATOR
References: