HIV SeropositivityOCTIHIVNCT02003989
Revealing Increased Axonal Loss in Treated HIV Patients
An observational study of HIV Seropositivity, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- ophthalmologic examination and MRI
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Seropositivity
- Being tested
- ophthalmologic examination and MRI
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmologic examination and MRIOther
thorough investigation of patients, not included in usual care.
| Study group | Role | What they receive |
|---|---|---|
| patients | HIV patients infected for more than ten years with undetectable viral load, undergoing ophthalmologic examination and MRI Receives: Other: ophthalmologic examination and MRI | |
| control | non HIV patients (same gender and age) undergoing ophthalmologic examination and MRI Receives: Other: ophthalmologic examination and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients
Measured: one day of examinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Cédric LAMIREL, Dr, Principal investigator, Fondation Ophtalmologique Adolphe de RothschildPhilippe GIRARD, Dr, Principal investigator, Institut Mutualiste MontsourisAntoine MOULIGNIE, Dr, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003989
- Sponsor's protocol ID
- RBM_CLL_2012-7
- Acronym
- OCTIHIV
- Status last verified
- May 2016
- First submitted
- 29 Nov 2013
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32155200
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealing Increased Axonal Loss in Treated HIV Patients
- ClinicalTrials.gov ID
- NCT02003989
- Acronym / sponsor ID
- OCTIHIV / RBM_CLL_2012-7
- Conditions
- HIV Seropositivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- May 2013
- Primary completion
- Aug 2015 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: ophthalmologic examination and MRIHIV patients infected for more than ten years with undetectable viral load, undergoing ophthalmologic examination and MRI |
| control | – | Other: ophthalmologic examination and MRInon HIV patients (same gender and age) undergoing ophthalmologic examination and MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ophthalmologic examination and MRIthorough investigation of patients, not included in usual care. | Other | control, patients |
Primary outcome
thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients
Time frame: one day of examinations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Derived from this study: PubMed 32155200Lamirel 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.
Related trials for HIV Seropositivity
Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
Idiopathic CD4 T Cell Lymphocytopenia
RecruitingObservational study
Thinking and Memory Problems in People With HIV
HIV Positive
Recruiting
Immuno-virological Evaluation of Persons Living With HIV (PLWH)
HIV-1-infection, HIV Seropositivity
Enrolling by invitation
A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP)
HIV Seropositivity
RecruitingObservational study
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
HIV, Seroconversion, HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric LAMIREL, Dr principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
Philippe GIRARD, Dr principal investigator
Institut Mutualiste Montsouris
Antoine MOULIGNIE, Dr principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients (time frame: one day of examinations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.