Revealing Increased Axonal Loss in Treated HIV Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fondation Ophtalmologique Adolphe de Rothschild
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT02003989
First received: November 29, 2013
Last updated: August 5, 2014
Last verified: August 2014

November 29, 2013
August 5, 2014
May 2013
February 2015   (final data collection date for primary outcome measure)
thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients [ Time Frame: one day of examinations ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02003989 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Revealing Increased Axonal Loss in Treated HIV Patients
Revealing Increased Axonal Loss in Treated HIV Patients

HIV patients may suffer sooner from aging than average population, including brain aging. Our hypothesis is that if brain dysfunctions are explained by a quicker loss of neurons in HIV patients, this loss could be detected earlier by a thinning down of retinal nerve fiber layer (RNFL), compared to non HIV patients of the same age.

The investigators aim to compare the thickness of the RNFL and the thickness of the RCGs measured by spectral domain OCT between patients infected by HIV and patients of same age non infected by HIV.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

HIV patients infected for at least 10 years with undetectable viral load, selected among infectious disease outpatients (consecutive exhaustive recruitment)

non HIV patients matched for age and gender

HIV Seropositivity
Other: ophthalmologic examination and MRI
thorough investigation of patients, not included in usual care.
  • patients
    HIV patients infected for more than ten years with undetectable viral load, undergoing ophthalmologic examination and MRI
    Intervention: Other: ophthalmologic examination and MRI
  • control
    non HIV patients (same gender and age) undergoing ophthalmologic examination and MRI
    Intervention: Other: ophthalmologic examination and MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection known since at least 10 years
  • viral load undetectable under ARV treatment since at least 5 years, whatever the type of ARV
  • lymphocytes CD4 > 350, whatever the CD4 nadir
  • signed informed consent

Exclusion Criteria:

  • History of ocular pathology, eye surgery, or intraocular injection
  • Familial History of glaucoma
  • ametropia (>3 dioptres on the sphere and >1,5 dioptres on the cylinder)
  • known neurological pathology, active or former
  • History of ethambutol or synthetic antimalarial drug consumption
  • History of chemotherapy
  • Active and regular use of drugs
  • non-weaned chronic alcoholism
  • contra indication to MRI
  • diabetes
  • cognitive disorders (MoCA<26)
  • non covered by health insurance
  • patient under legal protection
  • pregnant or breast-feeding woman
  • Non inclusion criteria for control patients: known HIV infection
Both
18 Years and older
No
France
 
NCT02003989
RBM_CLL_2012-7
No
Fondation Ophtalmologique Adolphe de Rothschild
Fondation Ophtalmologique Adolphe de Rothschild
Not Provided
Principal Investigator: Cédric LAMIREL, Dr Fondation Ophtalmologique Adolphe de Rothschild
Principal Investigator: Philippe GIRARD, Dr Institut Mutualiste Montsouris
Principal Investigator: Antoine MOULIGNIE, Dr Fondation Ophtalmologique Adolphe de Rothschild
Fondation Ophtalmologique Adolphe de Rothschild
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP