Status:
UNKNOWN
Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
HIV/AIDS
Mental Impairment
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole ...
Detailed Description
As efaviren has been commonly used as the first-line therapy in HIV infection worldwide, its major side effect i.e. the mental effects have been noticed and has a major influence on the adherence and ...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Willingness and availability to engage in study activities for the duration of the study
- Age between 18-65
- Documented HIV-1 infection (confirmed by Western blot)
- Received no prior antiretroviral therapy
Exclusion
- Pregnancy or breastfeeding or anticipated pregnancy in two years
- History of AIDS-defining illness
- Hemoglobin \< 9g/dl；or peripheral white blood cell counts \< 2000/μl；or neutrophil counts \< 1000 /μl；or platelet count \< 75,000/μl；
- Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
- Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
- Patients with a history of injection drug usage
- Patients with a history of mental disorders
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04463784
Start Date
April 1 2018
End Date
August 1 2021
Last Update
July 9 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730