Revealing Increased Axonal Loss in Treated HIV Patients (OCTIHIV)

October 20, 2016 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75019
        • Fondation OPH A de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients
Time Frame: one day of examinations
one day of examinations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBM_CLL_2012-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Seropositivity

Clinical Trials on ophthalmologic examination and MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe