Revealing Increased Axonal Loss in Treated HIV Patients

NCT ID: NCT02003989

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Seropositivity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients

HIV patients infected for more than ten years with undetectable viral load, undergoing ophthalmologic examination and MRI

ophthalmologic examination and MRI

Intervention Type OTHER

thorough investigation of patients, not included in usual care.

control

non HIV patients (same gender and age) undergoing ophthalmologic examination and MRI

ophthalmologic examination and MRI

Intervention Type OTHER

thorough investigation of patients, not included in usual care.

Interventions

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ophthalmologic examination and MRI

thorough investigation of patients, not included in usual care.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cédric LAMIREL, Dr

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild

Philippe GIRARD, Dr

Role: PRINCIPAL_INVESTIGATOR

Institut Mutualiste Montsouris

Antoine MOULIGNIE, Dr

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild

Locations

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Fondation OPH A de Rothschild

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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Lamirel C, Valin N, Savatovsky J, Lescure FX, Alonso AS, Girard P, Vincensini JP, Girard PM, Salomon L, Cochereau I, Moulignier A. Absence of peripapillary retinal nerve-fiber-layer thinning in combined antiretroviral therapy-treated, well-sustained aviremic persons living with HIV. PLoS One. 2020 Mar 10;15(3):e0229977. doi: 10.1371/journal.pone.0229977. eCollection 2020.

Reference Type DERIVED
PMID: 32155200 (View on PubMed)

Other Identifiers

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RBM_CLL_2012-7

Identifier Type: -

Identifier Source: org_study_id

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