HIVNCT01985399
Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro Study")
An observational study of HIV and AIDS, run by Stanford University at 1 site in United States.
Trial summary
Investigators hypothesize that older HIV-infected individuals (i.e., >50 years old) on efavirenz (EFV)-containing antiretroviral therapy (ART) will have significantly worse neurocognitive function than older individuals on non-EFV-containing ART. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- Neuropsychological testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 individuals on an EFV-containing regimen and 50 individuals on a protease-inhibitor (PI)-containing regimen
Who may be able to join
- Enrollment into SHAC (Stanford HIV Aging cohort)
- Age over 50 years of age
- Stable antiretroviral therapy containing EFV- or PI-containing ART (but not both) for at least 6 months
- HIV RNA levels of <200 copies/mL for at least 6 months excluding blips (i.e., a single measurement between 200-500 copies/mL preceded and followed by measurements of <200 copies/mL) while on ART.
Who cannot join
- Completed treatment for any acute systemic infection (other than HIV-1) less than four weeks before study entry
- Any active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
- Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound the analysis of the neuropsychological test results.
- Active drug or alcohol abuse that, in the investigator's opinion, could prevent compliance with study procedures or confound the analysis of study endpoints.
- Hospitalization within 30 days of study entry
- Receipt of systemic chemotherapy within 30 days of study entry
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University AIDS Clinical Trials Unit
Palo Alto, California, 94304
About this study
Investigators hypothesize that older HIV-infected individuals (i.e., >50 years old) on efavirenz (EFV)-containing antiretroviral therapy (ART) will have significantly worse neurocognitive function than older individuals on non-EFV-containing ART.
Read the detailed description
With the aging of the HIV-infected population in the United States and elsewhere, neurocognitive dysfunction will likely become an increasingly common problem. Older individuals could be at increased risk for efavirenz-associated adverse effects due to impaired metabolism, increased drug-drug interactions, and lower physiologic reserve, but there are few data on the long-term safety of efavirenz (and other antiretrovirals) in older individuals with HIV.
The Stanford HIV Aging Cohort (SHAC) is an ideal setting to study potential neurologic effects of antiretrovirals in aging patients. SHAC is an ongoing longitudinal study initiated in 2008 to evaluate aging in virologically-suppressed HIV-infected individuals. The cohort is supported through multiple grants including a grant from the State of California's HIV Research Program as well as a NIH supplemental grant. As of September 2013, approximately 150 virologically-suppressed HIV-infected adults have been enrolled. In addition to enrolling patients with good adherence to ART, the cohort purposefully excludes subjects with active substance abuse, unstable medical conditions, and psychiatric illnesses to limit potential confounding the study end points. Recently, an NIH supplemental grant (AI069556) was received which will expand the SHAC to 300 HIV-infected subjects. The median age of the subjects in the cohort is in the mid-50's allowing an ample number of older subjects for our planned studies.
- Being tested
- Neuropsychological testing
- Keywords
- HIV, AIDS, Aging
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingBehavioural
Neuropsychological testing
| Study group | Role | What they receive |
|---|---|---|
| EFV containing ARV regimen | Pts on Efavirenz containing ARV regimen will have neuropsychological testing performed Receives: Behavioral: Neuropsychological testing | |
| Non -EFV ontaning ARV regimen | Pts on a Non-Efavirenz containing ARVregimen will have neuropsychological testing measures performed Receives: Behavioral: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare a composite measure of neurocognitive function in older individuals on EFV-containing ART vs. non-EFV-containing ART.
Neurocognitive function will be assessed using a detailed battery of neuropsychologic tests including timed gait, grooved pegboard with the dominant and non-dominant hands, the Rey auditory verbal learning test trials I-VII, trail making parts A and B, Rey auditory verbal learning test trial VIII 30-min delay, controlled oral word association test and paced auditory serial addition task. This battery has been used extensively in previous studies in HIV. Z-scores for each neurocognitive test, based on age-adjusted norms, and a composite Z-score will be calculated. The Z-score represents the amount, in standard deviation units, that the subject's test result deviates from population means.
In addition to neurocognitive function, the level of depression and anxiety and sleep quality will be evaluated using validated instruments.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
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.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Services, LLC
- Responsible party
- Principal investigator, Philip Grant, Stanford University
- Investigators
- Philip Grant, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985399
- Sponsor's protocol ID
- SHAC Neuro Study
- Status last verified
- Oct 2016
- First submitted
- 4 Nov 2013
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro Study")
- ClinicalTrials.gov ID
- NCT01985399
- Acronym / sponsor ID
- SHAC Neuro Study
- Keywords
- HIV, AIDS, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Janssen Services, LLC
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Nov 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.
Investigators hypothesize that older HIV-infected individuals (i.e., >50 years old) on efavirenz (EFV)-containing antiretroviral therapy (ART) will have significantly worse neurocognitive function than older individuals on non-EFV-containing ART.
Detailed description
With the aging of the HIV-infected population in the United States and elsewhere, neurocognitive dysfunction will likely become an increasingly common problem. Older individuals could be at increased risk for efavirenz-associated adverse effects due to impaired metabolism, increased drug-drug interactions, and lower physiologic reserve, but there are few data on the long-term safety of efavirenz (and other antiretrovirals) in older individuals with HIV.
The Stanford HIV Aging Cohort (SHAC) is an ideal setting to study potential neurologic effects of antiretrovirals in aging patients. SHAC is an ongoing longitudinal study initiated in 2008 to evaluate aging in virologically-suppressed HIV-infected individuals. The cohort is supported through multiple grants including a grant from the State of California's HIV Research Program as well as a NIH supplemental grant. As of September 2013, approximately 150 virologically-suppressed HIV-infected adults have been enrolled. In addition to enrolling patients with good adherence to ART, the cohort purposefully excludes subjects with active substance abuse, unstable medical conditions, and psychiatric illnesses to limit potential confounding the study end points. Recently, an NIH supplemental grant (AI069556) was received which will expand the SHAC to 300 HIV-infected subjects. The median age of the subjects in the cohort is in the mid-50's allowing an ample number of older subjects for our planned studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFV containing ARV regimen | – | Behavioral: Neuropsychological testingPts on Efavirenz containing ARV regimen will have neuropsychological testing performed |
| Non -EFV ontaning ARV regimen | – | Behavioral: Neuropsychological testingPts on a Non-Efavirenz containing ARVregimen will have neuropsychological testing measures performed |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 individuals on an EFV-containing regimen and 50 individuals on a protease-inhibitor (PI)-containing regimen
Key inclusion criteria (4 listed)
- Enrollment into SHAC (Stanford HIV Aging cohort)
- Age over 50 years of age
- Stable antiretroviral therapy containing EFV- or PI-containing ART (but not both) for at least 6 months
- HIV RNA levels of <200 copies/mL for at least 6 months excluding blips (i.e., a single measurement between 200-500 copies/mL preceded and followed by measurements of <200 copies/mL) while on ART.
Key exclusion criteria (7 listed)
- Completed treatment for any acute systemic infection (other than HIV-1) less than four weeks before study entry
- Any active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
- Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound the analysis of the neuropsychological test results.
- Active drug or alcohol abuse that, in the investigator's opinion, could prevent compliance with study procedures or confound the analysis of study endpoints.
- Hospitalization within 30 days of study entry
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 |
|---|---|---|
| Neuropsychological testingNeuropsychological testing | Behavioural | EFV containing ARV regimen, Non -EFV ontaning ARV regimen |
Primary outcome
Compare a composite measure of neurocognitive function in older individuals on EFV-containing ART vs. non-EFV-containing ART.
Time frame: one year
Neurocognitive function will be assessed using a detailed battery of neuropsychologic tests including timed gait, grooved pegboard with the dominant and non-dominant hands, the Rey auditory verbal learning test trials I-VII, trail making parts A and B, Rey auditory verbal learning test trial VIII 30-min delay, controlled oral word association test and paced auditory serial addition task. This battery has been used extensively in previous studies in HIV. Z-scores for each neurocognitive test, based on age-adjusted norms, and a composite Z-score will be calculated. The Z-score represents the amount, in standard deviation units, that the subject's test result deviates from population means. In addition to neurocognitive function, the level of depression and anxiety and sleep quality will be evaluated using validated instruments.
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 17 Oct 2016.
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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.
Philip Grant, MD principal investigator
Stanford University
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 and AIDS, run by Stanford University at 1 site in United States.
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 7 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 17 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 United States. 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?
Compare a composite measure of neurocognitive function in older individuals on EFV-containing ART vs. non-EFV-containing ART. (time frame: one year). 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 17 Oct 2016.