Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine

NCT ID: NCT03567304

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-06
• Study Completion Date: 2020-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EFV-based

HIV-infected patients, who has been taking efavirenz (EFV)-based regimen for at least 1 year and is diagnosed with asymptomatic neurocognitive impairment (ANI) or mild neurocognitive disease (MND) by neurocognitive battery tests, is randomized to continue EFV-based regimen.

EFV based regimen defines as efavirenz 600 mg per oral once daily (OD) + 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

Group Type: NO_INTERVENTION

No interventions assigned to this group

RPV-based

HIV-infected patients, who has been taking efavirenz-based regimen for at least 1 year and is diagnosed with asymptomatic neurocognitive impairment (ANI) or mild neurocognitive disease (MND) by neurocognitive battery tests, is randomized to switch antiretroviral therapy to rilpivirine (RPV)-based regimen.

RPV based regimen defines as rilpivirine 25 mg PO OD + 2 NRTIs.

Group Type: EXPERIMENTAL

Rilpivirine 25 mg

Intervention Type: DRUG

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

Interventions

Rilpivirine 25 mg

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

Intervention Type: DRUG

Other Intervention Names

Switching from EFV to RPV

Eligibility Criteria

Inclusion Criteria

• Documented HIV infection
• Age 20 years old and above
• On EFV-based regimen (EFV and 2 Nucleoside Reverse Transcriptase Inhibitors) for at least 1 year prior to enrollment
• CD4 ≥ 200 cell/mm3 and viral load < 200 copies/mL within 12 months before enrollment
• Able to be read and write in Thai language
• Willing to sign informed consent and able to follow up
• The neurocognitive battery test is compatible with asymptomatic neurocognitive impairment (ANI) or mild neurocognitive disorder (MND) using Frascati's criteria

Exclusion Criteria

• History of Traumatic Brain Injury, Developmental delay or intellectual deficit, or other neurological conditions have deleterious effects on neurocognitive test based on investigator opinion.
• Active syphilis or on going to treatment with positive for syphilis serological marker (rapid plasma reagin; RPR) in 3 Months before entry study
• Pregnancy
• Renal failure (creatinine clearance < 30 mL/min)
• Transaminitis in the past 3 months (≥5 UNL) Or Decompensated cirrhosis (child-pugh C)
• Moderate depressive score; Patient Health Questionnaire-9 score ≥ 10)
• Positive for any hepatitis B virus and hepatitis C virus serological marker in 3 Months before entry study
• History of treatment failure or drug resistance to EFV and or RPV
• Not suitable or contraindication for RPV (continue proton pump inhibitor drug)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Quanhathai Kaewpoowat

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quanhathai Kaewpoowat, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Faculty of Medicine, Chiang Mai University, Thailand.

Locations

Chiang Mai University Hospital

Chiang Mai, , Thailand

Countries

Thailand

Other Identifiers

MED-2561-05276

Identifier Type: -

Identifier Source: org_study_id