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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02003989
Other study ID # RBM_CLL_2012-7
Secondary ID
Status Completed
Phase N/A
First received November 29, 2013
Last updated October 20, 2016
Start date May 2013

Study information

Verified date May 2016
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
ophthalmologic examination and MRI
thorough investigation of patients, not included in usual care.

Locations

Country Name City State
France Fondation OPH A de Rothschild Paris Ile de France

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients one day of examinations No
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