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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro Study")|
- 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.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01985399
|Contact: Philip Grant, MDemail@example.com|
|Contact: Debbie Slamowitz, RNfirstname.lastname@example.org|
|United States, California|
|Stanford University AIDS Clinical Trials Unit||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Philip Grant, MD 650-723-9001 email@example.com|
|Contact: Debbie Slamowitz, RN 650-723-2804 firstname.lastname@example.org|
|Principal Investigator: Philip Grant, MD|
|Principal Investigator: Andrew Zolopa, MD|
|Principal Investigator:||Philip Grant, MD||Stanford University|