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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02154971
Recruitment Status : Recruiting
First Posted : June 4, 2014
Last Update Posted : February 14, 2017
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.

Condition or disease
HIV Seropositivity

Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Age-related Hearing Loss in HIV-1 Patients
Study Start Date : November 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy
non-HIV (matched for age and gender)

Primary Outcome Measures :
  1. hearing loss at several frequencies [ Time Frame: Baseline ]
    Measurement by audiometry (pure tone and speech audiometry at 500Hz, 1000Hz, 2000Hz, 3000Hz and 8000 Hz), expressed in dB.

Secondary Outcome Measures :
  1. threshold for speech intelligibility [ Time Frame: Baseline ]
    measured by speech audiometry

  2. Proportion of patients with neuropathic hearing loss [ Time Frame: Baseline ]
  3. Interval I-V on the evoked-response audiogram [ Time Frame: Baseline ]
  4. Maximum speech intelligibility [ Time Frame: Baseline ]
    Measured by speech audiometry

  5. Proportion of patients with age-related hearing loss [ Time Frame: Baseline ]

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)
  • MRI contraindication
  • Known pregnancy or breastfeeding woman
  • No medical insurance coverage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT02154971     History of Changes
Other Study ID Numbers: AMR_2013-10
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

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

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