HIV/AIDS Clinical Trial
Official title:
The Efficacy and Safety of Ainuovirine in the Treatment of HIV-infected/AIDS Patients in China
Ainuovirine is the third generation of non nucleoside reverse transcriptase inhibitors(NNRTIs), for the treatment of HIV-1 infected adults. The existing clinical studies show that Ainuovirine is safe and potent, it solves the problem from the first-generation NNRTIs such as Efavirenz with large side effects and the second-generation like Rilpivirine not suitable for high viral load, but there are no relevant data or reports on the efficacy and safety of Ainuovirine in HIV-infected patients in China so far. This project aims to explore the efficacy and safety of ART regimens containing Ainuovirine for HIV-infected patients in real clinical environment, in further to guide clinical application.
This study is an open-label, multicentered, single-arm and phase IV clinical trial. 450 HIV-infected patients who received Ainuovirine regimen (150mg, oral, qd) were included. At day 1 (1st collection as day 1), 3rd, 6th, 9th, 12th month, the rate of viral suppression and CD4+T cell count were calculated against baseline. In addition, the safety and drug compliance were also monitored. Other indicators: Demographic data (including gender, ethnicity, age, height, education level, occupation, route of infection), past medical history, smoking history, drug abuse history, hepatitis B markers, hepatitis C antibody, B ultrasound, chest X-ray, electrocardiogram, pregnancy test (Females of childbearing age): Day 1 (1st collection as Day 1), 1 time in total. Vital signs (heart rate, blood pressure), body weight: 5 times on day 1 (the 1st collection was taken as day 1), 3rd, 6th, 9th, and 12th months. ;
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