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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Stanford University
Janssen Services, LLC
Information provided by (Responsible Party):
Stanford University Identifier:
First received: November 4, 2013
Last updated: November 17, 2014
Last verified: November 2014

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.

Condition Intervention
Behavioral: Neuropsychological testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro Study")

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Efavirenz containing Antiretroviral regimen
Patients currently on Efavirenz containing Antiretroviral regimen will have neuropsychological testing performed
Behavioral: Neuropsychological testing
Non -Efavirenz contaning Antiretroviral regimen
Patients on a Non-Efavirenz containing Antiretroviral regimen will have neuropsychological testing measures performed
Behavioral: Neuropsychological testing

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.


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01985399

Contact: Philip Grant, MD 650-723-9001
Contact: Debbie Slamowitz, RN 650-723-2804

United States, California
Stanford University AIDS Clinical Trials Unit Recruiting
Palo Alto, California, United States, 94304
Contact: Philip Grant, MD    650-723-9001   
Contact: Debbie Slamowitz, RN    650-723-2804   
Principal Investigator: Philip Grant, MD         
Principal Investigator: Andrew Zolopa, MD         
Sponsors and Collaborators
Stanford University
Janssen Services, LLC
Principal Investigator: Philip Grant, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Stanford University Identifier: NCT01985399     History of Changes
Other Study ID Numbers: SHAC Neuro Study
Study First Received: November 4, 2013
Last Updated: November 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on March 26, 2015