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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Fondation Ophtalmologique Adolphe de Rothschild
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild Identifier:
First received: June 2, 2014
Last updated: May 18, 2016
Last verified: May 2016

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.

HIV Seropositivity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Age-related Hearing Loss in HIV-1 Patients

Resource links provided by NLM:

Further study details as provided by Fondation Ophtalmologique Adolphe de Rothschild:

Primary Outcome Measures:
  • hearing loss at several frequencies [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.

Secondary Outcome Measures:
  • threshold for speech intelligibility [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    measured by speech audiometry

  • Proportion of patients with neuropathic hearing loss [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Interval I-V on the evoked-response audiogram [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Maximum speech intelligibility [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measured by speech audiometry

  • Proportion of patients with age-related hearing loss [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: November 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy
non-HIV (matched for age and gender)


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02154971

Contact: Antoine Moulignier, MD +33 148 036 778

Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, Ile de France, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Principal Investigator: Antoine Moulignier, MD Fondation Ophtalmologique Antoine de Rothschild
  More Information

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT02154971     History of Changes
Other Study ID Numbers: AMR_2013-10 
Study First Received: June 2, 2014
Last Updated: May 18, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
HIV Seropositivity
Hearing Loss

Additional relevant MeSH terms:
HIV Seropositivity
Hearing Loss
Ear Diseases
HIV Infections
Hearing Disorders
Hearing Loss, Sensorineural
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
RNA Virus Infections
Retroviridae Infections
Sensation Disorders
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Virus Diseases processed this record on May 25, 2016