Assessment of Age-related Hearing Loss in HIV-1 Patients (HELO)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: HIV Seropositivity

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02154971

AMR_2013-10

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

206 participants in 2 patient groups

Patients

Description:

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

Control

Description:

non-HIV (matched for age and gender)