Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03661203 - Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM
Completed NCT00381212 - A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent. Phase 1/Phase 2
Not yet recruiting NCT05983536 - The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
Recruiting NCT04832477 - Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US N/A
Active, not recruiting NCT04044586 - HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)
Completed NCT03218839 - Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males N/A
Active, not recruiting NCT00797030 - Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus Phase 4
Recruiting NCT04088916 - Proviral DNA as a Target for HIV-1 Resistance Analysis
Completed NCT03367130 - Improving Clinic Attendance for Medication Collection Among HIV Positive Individuals in Nepal N/A
Completed NCT04849767 - National Survey About Trajectory and Life Conditions of HIV Trans People in France
Completed NCT05674682 - Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study N/A
Recruiting NCT05174234 - Precariousness and Sexual Vulnerability of People From Haiti Living With or Without HIV in French Guiana
Completed NCT00130819 - Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants Phase 2
Active, not recruiting NCT04706624 - Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics N/A
Recruiting NCT03858478 - Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST Phase 4
Completed NCT02154971 - Assessment of Age-related Hearing Loss in HIV-1 Patients
Recruiting NCT03333083 - Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen Phase 3
Recruiting NCT03311945 - Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Phase 3
Recruiting NCT03795415 - ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali
Completed NCT01813292 - Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine N/A