Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiang Mai University
• Treatments: Efavirenz; Rilpivirine

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)