Revealing Increased Axonal Loss in Treated HIV Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
HIV Seropositivity
Other: ophthalmologic examination and MRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Revealing Increased Axonal Loss in Treated HIV Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients
HIV patients infected for more than ten years with undetectable viral load, undergoing ophthalmologic examination and MRI
Other: ophthalmologic examination and MRI
thorough investigation of patients, not included in usual care.
control
non HIV patients (same gender and age) undergoing ophthalmologic examination and MRI
Other: ophthalmologic examination and MRI
thorough investigation of patients, not included in usual care.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT02003989

Locations
France
Fondation OPH A de Rothschild Recruiting
Paris, Ile de France, France, 75019
Contact: Cédric Lamirel, MD, PhD    0033148036431    clamirel@fo-rothschild.fr   
Contact: Laurence Salomon, MD, PhD    0033148036431    lsalomon@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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
  More Information

No publications provided

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02003989     History of Changes
Other Study ID Numbers: RBM_CLL_2012-7
Study First Received: November 29, 2013
Last Updated: December 5, 2013
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014