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

NCT01985399 | Completed

• 1 other identifier: SHAC Neuro Study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; AIDS

Keywords

HIV; AIDS; Aging

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (2)

EFV containing ARV regimen

Pts on Efavirenz containing ARV regimen will have neuropsychological testing performed

Behavioral: Neuropsychological testing

Non -EFV ontaning ARV regimen

Pts on a Non-Efavirenz containing ARVregimen will have neuropsychological testing measures performed

Behavioral: Neuropsychological testing

Interventions

Neuropsychological testing BEHAVIORAL

Neuropsychological testing

EFV containing ARV regimen; Non -EFV ontaning ARV regimen

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Janssen Services, LLC: collaborator

Study Sites (1)

Stanford University AIDS Clinical Trials Unit

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Philip Grant, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 15, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

US (1)