Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Efavirenz

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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