Clinical trial NCT02003989: Revealing Increased Axonal Loss in Treated HIV Patients
Official title: Revealing Increased Axonal Loss in Treated HIV Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Seropositivity
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2013-12-06
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients
timeFrame: one day of examinations
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation OPH A de Rothschild
state: Ile de France
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Cédric LAMIREL, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Mutualiste Montsouris
name: Philippe GIRARD, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Antoine MOULIGNIE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.