AIDS-Related Dementia ComplexOCT-HIVNCT02431091
Evaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder
A study testing Optical Coherence Tomography in people with AIDS-Related Dementia Complex, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI and usual cognitive screening tools. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS-Related Dementia Complex
- What is being tested?
- Optical Coherence Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Mar 2022
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection
- Antiretroviral treatment
- Undetectable plasmatic HIV viral load (viral load<50 copies/ml) for at least 6 months
- Ability to understand and give approved consent
Who cannot join
- Any present or past ophthalmologic illness that may impair OCT results
- Previous cerebral infection with sequel
- Previous cerebrovascular disease with sequel
- Severe psychiatric illness
- Active alcohol or drug abuse
- Active chronic hepatitis C
Show all 9Show fewer
- Inability to perform french cognitive assessment
- Inability to perform a MRI
- Inability to perform a lumbar puncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of Optical Coherence Tomography (OCT) in the Detection of HIV-associated Neurocognitive Disorder
The purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI and usual cognitive screening tools.
- Conditions
- AIDS-Related Dementia Complex
- Being tested
- Optical Coherence Tomography
- Keywords
- Optical Coherence Tomography
- Medical subject headings
- AIDS Dementia Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyOther
Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina
| Study group | Role | What they receive |
|---|---|---|
| Definite Case | Experimental | Patients with abnormal response on both the screening questions and at least one of the cognitive screening tests.
Optical Coherence Tomography is performed in all definite cases Receives: Other: Optical Coherence Tomography |
| Control | Active comparator | Patients with normal response on both the screening questions and all the cognitive screening tests.
Optical Coherence Tomography is performed in matched control A patients Receives: Other: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation
Measured: Baseline
Secondary outcomes (2)
Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation
Measured: Baseline
Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS-Related Dementia ComplexStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds iris-Recherche, Fondation Roi Baudouin, Belgium
- Responsible party
- Principal investigator, Agnès Libois, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Stéphane Dewit, PhD, Study director, CHU St Pierre, Service des Maladies Infectieuses
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431091
- Sponsor's protocol ID
- CHUSTP-OCTHIV
- Acronym
- OCT-HIV
- Status last verified
- Mar 2022
- First submitted
- 22 Apr 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Optical Coherence Tomography (OCT) in the Detection of HIV-associated Neurocognitive Disorder
- ClinicalTrials.gov ID
- NCT02431091
- Acronym / sponsor ID
- OCT-HIV / CHUSTP-OCTHIV
- Conditions
- AIDS-Related Dementia Complex
- Keywords
- Optical Coherence Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Fonds iris-Recherche, Fondation Roi Baudouin, Belgium
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 30 Apr 2015 (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.
The purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI and usual cognitive screening tools.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Definite Case | Experimental | Other: Optical Coherence TomographyPatients with abnormal response on both the screening questions and at least one of the cognitive screening tests. Optical Coherence Tomography is performed in all definite cases |
| Control | Active comparator | Other: Optical Coherence TomographyPatients with normal response on both the screening questions and all the cognitive screening tests. Optical Coherence Tomography is performed in matched control A patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infection
- Antiretroviral treatment
- Undetectable plasmatic HIV viral load (viral load<50 copies/ml) for at least 6 months
- Ability to understand and give approved consent
Key exclusion criteria (9 listed)
- Any present or past ophthalmologic illness that may impair OCT results
- Previous cerebral infection with sequel
- Previous cerebrovascular disease with sequel
- Severe psychiatric illness
- Active alcohol or drug abuse
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 |
|---|---|---|
| Optical Coherence TomographyOptical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina | Other | Control, Definite Case |
Primary outcome
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation
Time frame: Baseline
2 secondary outcomes
Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation
Time frame: Baseline
Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)
Time frame: Baseline
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 31 Mar 2022.
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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.
Stéphane Dewit, PhD study director
CHU St Pierre, Service des Maladies Infectieuses
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography in people with AIDS-Related Dementia Complex, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 9 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 31 Mar 2022. 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 Belgium. 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?
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.