Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro Study")

This study is not yet open for participant recruitment.
Verified November 2013 by Stanford University
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01985399
First received: November 4, 2013
Last updated: November 8, 2013
Last verified: November 2013

November 4, 2013
November 8, 2013
December 2013
December 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01985399 on ClinicalTrials.gov Archive Site
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Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro Study")
Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

50 individuals on an EFV-containing regimen and 50 individuals on a protease-inhibitor (PI)-containing regimen

  • HIV
  • AIDS
Behavioral: Neuropsychological testing
  • Efavirenz containing Antiretroviral regimen
    Patients currently on Efavirenz containing Antiretroviral regimen will have neuropsychological testing performed
    Intervention: Behavioral: Neuropsychological testing
  • Non -Efavirenz contaning Antiretroviral regimen
    Patients on a Non-Efavirenz containing Antiretroviral regimen will have neuropsychological testing measures performed
    Intervention: Behavioral: Neuropsychological testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
50 Years and older
No
Contact: Philip Grant, MD 650-723-9001 pmgrant@stanford.edu
Contact: Debbie Slamowitz, RN 650-723-2804 dslam@stanford.edu
United States
 
NCT01985399
SHAC Neuro Study
No
Stanford University
Stanford University
Janssen Services, LLC
Principal Investigator: Philip Grant, MD Stanford University
Stanford University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP