Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro Study")
Completed
Conditions studied: HIV, AIDS
In brief
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.
Key facts
- Study ID
- NCT01985399
- Run by
- Stanford University
- People needed
- 100
- Starts
- 2013-12-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-10-17
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Stanford University AIDS Clinical Trials Unit — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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