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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Fondation Ophtalmologique Adolphe de Rothschild
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT02154971
First received: June 2, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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.

70 HIV positive patients and 70 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
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: 70
Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
HIV infected for more than 10 years, aged over 40, treated with antiretroviral therapy
Control
non-HIV (matched for age and gender)

  Eligibility

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

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

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 ClinicalTrials.gov identifier: NCT02154971

Contacts
Contact: Antoine Moulignier, MD +33 148 036 778 amoulignier@fo-rothschild.fr

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

No publications provided

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

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

Additional relevant MeSH terms:
Hearing Loss
Deafness
HIV Seropositivity
Presbycusis
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

ClinicalTrials.gov processed this record on September 18, 2014