HIV/AIDS Clinical Trial
Official title:
Peking Union Medical College Hospital
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.
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 efficacy of ART regimen. Mental effects of efaviren have been especially
critical in Chinese patients, as the effective and toxic ranges of efaviren plasma
concentration in Chinese patients are very close to each other.
In this study, 500 treatment-naive Chinese patients with a body weight < 60kg will be
screened and recruited. Patients will be randomized 1:1 to efaviren 400mg v.s. 600mg combined
with lamivudine and tenofovir. All patients will be followed regularly for 2 years, at 0, 2w,
4w, 3m and every 3 months. Virological and immunological measurements will be done at each
visit. Meanwhile, various mental scales will be performed at each visit to evaluate the
mental effects of each arm.
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