Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine

NCT03567304 | Unknown Phase 4

• 1 other identifier: MED-2561-05276
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection; Neurocognitive Dysfunction

Keywords

HIV; Neurocognitive disorder; Efavirenz; Rilpivirine

Outcome Measures

Primary Outcomes (1)

• Change of neurocognitive function

  Improvement is defined by changing neurocognitive status based on Frascati's criteria (using neurocognitive battery tests) 1) from Asymptomatic neurocognitive impairment (ANI) to normal OR 2) from Mild neurocognitive disorder; MND to ANI or normal.

  12 months

Secondary Outcomes (3)

• Overall Global Deficit Score of all neurocognitive domains

  12 months

• Adverse reactions after switching from EFV to RPV

  12 months

• Prevalence of neurocognitive disorder among HIV-infected patients who has received EFV for at least 1 year

  3 months

Study Arms (2)

EFV-based

NO INTERVENTION

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).

RPV-based

EXPERIMENTAL

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.

Drug: Rilpivirine 25 mg

Interventions

Rilpivirine 25 mg DRUG

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

Also known as: Switching from EFV to RPV

RPV-based

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Chiang Mai University Hospital

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Cognition Disorders; Neurocognitive Disorders

Interventions

Rilpivirine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Quanhathai Kaewpoowat, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 25, 2018
• Study Start: July 6, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

TH (1)