Revealing Increased Axonal Loss in Treated HIV Patients
OCTIHIV
1 other identifier
observational
156
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 29, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedOctober 21, 2016
May 1, 2016
2.3 years
November 29, 2013
October 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients
one day of examinations
Study Arms (2)
patients
HIV patients infected for more than ten years with undetectable viral load, undergoing ophthalmologic examination and MRI
control
non HIV patients (same gender and age) undergoing ophthalmologic examination and MRI
Interventions
thorough investigation of patients, not included in usual care.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation OPH A de Rothschild
Paris, Île-de-France Region, 75019, France
Related Publications (1)
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.
PMID: 32155200DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2013
First Posted
December 6, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2015
Last Updated
October 21, 2016
Record last verified: 2016-05