Revealing Increased Axonal Loss in Treated HIV Patients

HIV Seropositivity Clinical Trial

— OCTIHIV  

Official title:

Revealing Increased Axonal Loss in Treated HIV Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003989
• Other study ID #: RBM_CLL_2012-7
• 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. 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

• HIV Seropositivity

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