HIVALCOVENCT02852772
Does Micro-albuminuria is a Predictive Factor for Cognitive Impairment in Persons Living With HIV (PLHIV) Who Achieve cART-sustained Immunovirological Control ?
An observational study of HIV, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment. Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably affecting the small vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Cognitive function tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to 7 Nov 2016
- 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: Patients registered in the HIVREINE database (which combines nephrology and infectious diseases services of AP-HP, Greater Paris University Hospitals)
Who may be able to join
- Known HIV infection for at least 5 years
- Undetectable viral load under antiretroviral (ARV) treatment for at least 1 year, regardless of the type of ARV
- Number of CD4 ≥ 350, regardless of the CD4 nadir
- Unopposed to participate to the study
- For cases
- Micro-albuminuria defined by microalbuminuria / creatinuria between 3 and 30 mg/mmol
- For controls, matched for age +/- 5 years - Absence of microalbuminuria defined by microalbuminuria / creatinuria <3 mg/mmol
Who cannot join
- Known neurological disease, active or former
- Active and regular use of drugs
- Active Chronic alcoholism
- Diabetes with known complications
- Renal failure with glomerular filtration rate <15 ml / min
- Micro-albuminuria / creatinuria> 30 mg / mmol
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- HIVAN
- Unbalanced arterial hypertension
- Patient did not have dosing glucose and lipid levels in over a year
- Unaffiliated patient (or copyright holder) to a social security scheme
- People enjoying a measure of legal protection Pregnant or breastfeeding
- Secondary exclusion criteria
- Neurological disease found during the assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment. Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably affecting the small vessels. In the older general population microalbuminuria is associated with greater annual cognitive decline and has been proposed as an easily and inexpensive measured marker predicting future cognitive function decline. Ageing of the PLH leads to an increase of cognitive disorders and chronic renal failure incidence and could imply a common underlying mechanism affecting the renal and cerebral microvasculature. In this setting the investigators undertake this prospective, cross-sectional, case-control study to determine whether the presence of a microalbuminuria at least 5 years ago in PLHs with sustained good combination antiretroviral therapy (cART)-controlled immunovirological parameters could be a marker predicting future cognitive impairment. They chose PLHs infected for at least 5 years and with cART-sustained immunovirological control for at least 1 year.
- Conditions
- HIV
- Being tested
- Cognitive function tests
- Keywords
- Cognitive impairment, HIV, Microalbuminuria, Chronic kidney disease
- Medical subject headings
- Cognitive Dysfunction, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive function testsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| PLHIV with microalbuminuria | Patient infected with HIV and well controlled by treatments, with microalbuminuria for at least 5 years Receives: Behavioral: Cognitive function tests | |
| PLHIV without microalbuminuria (control) | Patient infected with HIV and well controlled by treatments, without microalbuminuria, matched for age +/- 5 years Receives: Behavioral: Cognitive function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-Score of five neurocognitive domains tested and global deficit score
Comparisons of composite cognitive scores (z-score) and scores of global cognitive deficits (GDS) between the two populations. The neuropsychological tests are made during a single consultation of a half day.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2014
- Primary completion7 Nov 2016
- Study completion7 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852772
- Sponsor's protocol ID
- AMR_2014-2
- Acronym
- ALCOVE
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Micro-albuminuria is a Predictive Factor for Cognitive Impairment in Persons Living With HIV (PLHIV) Who Achieve cART-sustained Immunovirological Control ?
- ClinicalTrials.gov ID
- NCT02852772
- Acronym / sponsor ID
- ALCOVE / AMR_2014-2
- Conditions
- HIV
- Keywords
- Cognitive impairment, HIV, Microalbuminuria, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jul 2014
- Primary completion
- 7 Nov 2016 (actual)
- Study completion
- 7 Nov 2016 (actual)
- First posted
- 2 Aug 2016 (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.
Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment. Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably affecting the small vessels. In the older general population microalbuminuria is associated with greater annual cognitive decline and has been proposed as an easily and inexpensive measured marker predicting future cognitive function decline. Ageing of the PLH leads to an increase of cognitive disorders and chronic renal failure incidence and could imply a common underlying mechanism affecting the renal and cerebral microvasculature. In this setting the investigators undertake this prospective, cross-sectional, case-control study to determine whether the presence of a microalbuminuria at least 5 years ago in PLHs with sustained good combination antiretroviral therapy (cART)-controlled immunovirological parameters could be a marker predicting future cognitive impairment. They chose PLHs infected for at least 5 years and with cART-sustained immunovirological control for at least 1 year.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLHIV with microalbuminuria | – | Behavioral: Cognitive function testsPatient infected with HIV and well controlled by treatments, with microalbuminuria for at least 5 years |
| PLHIV without microalbuminuria (control) | – | Behavioral: Cognitive function testsPatient infected with HIV and well controlled by treatments, without microalbuminuria, matched for age +/- 5 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registered in the HIVREINE database (which combines nephrology and infectious diseases services of AP-HP, Greater Paris University Hospitals)
Key inclusion criteria (7 listed)
- Known HIV infection for at least 5 years
- Undetectable viral load under antiretroviral (ARV) treatment for at least 1 year, regardless of the type of ARV
- Number of CD4 ≥ 350, regardless of the CD4 nadir
- Unopposed to participate to the study
- For cases
Key exclusion criteria (13 listed)
- Known neurological disease, active or former
- Active and regular use of drugs
- Active Chronic alcoholism
- Diabetes with known complications
- Renal failure with glomerular filtration rate <15 ml / min
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 |
|---|---|---|
| Cognitive function tests | Behavioural | PLHIV with microalbuminuria, PLHIV without microalbuminuria (control) |
Primary outcome
Z-Score of five neurocognitive domains tested and global deficit score
Time frame: 4 hours
Comparisons of composite cognitive scores (z-score) and scores of global cognitive deficits (GDS) between the two populations. The neuropsychological tests are made during a single consultation of a half day.
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 28 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 7 inclusion and 13 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 28 Jul 2017. 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?
Z-Score of five neurocognitive domains tested and global deficit score (time frame: 4 hours). 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 28 Jul 2017.