HIV-1-infection Clinical Trial
Official title:
Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine in HIV-infected Adults: A Randomized Control Trial
Verified date | July 2019 |
Source | Chiang Mai University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 28 |
Est. completion date | July 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Thailand | Chiang Mai University Hospital | Chiang Mai |
Lead Sponsor | Collaborator |
---|---|
Chiang Mai University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall Global Deficit Score of all neurocognitive domains | All neurocognitive domains will be evaluated at 12 months after randomization which include; Verbal and language, Attention and working memory, Abstraction and executive function, Memory (learning, recall), Speed of information processing, and Sensory-perceptual and motor skills. The Global Deficit Score (min of 0, max of 5) of overall performance will be compared. | 12 months | |
Secondary | Adverse reactions after switching from EFV to RPV | Adverse reactions of RPV will be recorded | 12 months | |
Secondary | Prevalence of neurocognitive disorder among HIV-infected patients who has received EFV for at least 1 year | The prevalence of neurocognitive disorder (in percentage), will be evaluated among participants during the screening process. | 3 months |
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