NCT03567304

Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine

Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine in HIV-infected Adults: A Randomized Control Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

People living with HIV in the era of antiretroviral therapy (ART) continue to suffer high rates of neurocognitive disorder. This is a randomized control trial aiming to evaluate improvement of neurocognitive function after switching efavirenz (EFV) to rilpivirine (RPV). EFV based regimen is currently the first line ART in Thailand. There are several reports suggested that HIV-infected patients who took EFV based regimen had poorer neurocognitive function compared to the comparator. RPV, another first line regimen, has been known to have less neuropsychiatric side effects. We hypothesized that switching EFV to RPV could improve neurocognitive function.

Detailed description

People living with HIV (PLWH) in the era of antiretroviral therapy (ART) continue to suffer high rates of neurocognitive disorder. Previous report revealed that 36% of PLWH in Thailand had this condition. There are several reports suggested that HIV-infected patients who took efavirenz (EFV) based regimen had poorer neurocognitive function compared to the comparator. Rilpivirine (RPV), another first line regimen, has been known to have less neuropsychiatric side effects. We hypothesized that switching EFV to RPV could improve long term neurocognitive function. PLWH (20 years and older) who received EFV-based regimen for at least 1 years at Chiang Mai University Hospital will be invited to this study. Neurocognitive function will be evaluated using 3 screening questions, International HIV Dementia Scale, Montreal Cognitive Assessment, and comprehensive neurocognitive battery test evaluating 6 different cognitive domains. The participants will be categorized in to 4 groups based on their neurocognitive test results; no evidence of neurocognitive deficit, asymptomatic neurocognitive impairment (ANI), mild neurocognitive disease (MND), and HIV associated dementia (HAD) using Frascati's criteria. The participants with ANI or MND and meet the eligibility criteria will be enrolled to this study. The participants will be randomized in to 2 arms; continuing EFV-based regimen or switching to RPV-based regimen. Neurocognitive function will be evaluated at 6 and 12 months.

Conditions

• HIV-1-infection
• Neurocognitive Dysfunction

Interventions

Type	Name	Description
DRUG	Rilpivirine 25 mg	Rilpivirine 25 mg PO OD with meal (and continue 2 back bone of NRTIs)

Timeline

• Start date: 2018-07-06
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2018-06-25
• Last updated: 2019-07-24

Locations

1 site across 1 country: Thailand