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

HIV Seropositivity Clinical Trial

— HELO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154971
• Other study ID #: AMR_2013-10
• Status: Completed
• Start date: November 18, 2013
• Est. completion date: February 26, 2019

Study information

• Verified date: September 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• HIV Seropositivity
• Presbycusis

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

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