Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection
NCT04463784 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2020-07-09
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 cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study.
Conditions
- HIV/AIDS
- Mental Impairment
Interventions
- DRUG
-
Efavirenz 400Mg Oral Tablet
The experimental arm will receive 400mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
- DRUG
-
Efavirenz 600Mg Oral Tablet
The active comparator arm will receive 600mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Taisheng Li, PhD, MD · Peking Union Medical College Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2020-12-31
- Completion
- 2021-08-31
Countries
- China
Study Locations
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