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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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
HIV
AIDS
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.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01985399

Contacts
Contact: Philip Grant, MD 650-723-9001 pmgrant@stanford.edu
Contact: Debbie Slamowitz, RN 650-723-2804 dslam@stanford.edu

Locations
United States, California
Stanford University AIDS Clinical Trials Unit Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Philip Grant, MD    650-723-9001    pmgrant@stanford.edu   
Contact: Debbie Slamowitz, RN    650-723-2804    dslam@stanford.edu   
Principal Investigator: Philip Grant, MD         
Principal Investigator: Andrew Zolopa, MD         
Sponsors and Collaborators
Stanford University
Janssen Services, LLC
Investigators
Principal Investigator: Philip Grant, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01985399     History of Changes
Other Study ID Numbers: SHAC Neuro Study
Study First Received: November 4, 2013
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
HIV
AIDS
Aging

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014