OCTIHIV: Revealing Increased Axonal Loss in Treated HIV Patients

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Completed
• CT.gov ID: NCT02003989
• Collaborator: (none)
• Enrollment: 156
• Location: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV Seropositivity	Other: ophthalmologic examination and MRI

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 Design

• Study Type: Observational
• Actual Enrollment: 156 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Revealing Increased Axonal Loss in Treated HIV Patients
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Aug 1, 2015

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients [one day of examinations]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Fondation OPH A de Rothschild	Paris	Ile de France	France	75019

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT02003989
• Other Study ID Numbers: RBM_CLL_2012-7
• First Posted: Dec 6, 2013
• Last Update Posted: Oct 21, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: HIV Seropositivity

Study Results

No Results Posted as of Oct 21, 2016