Efficacy and Safety of Ainuovirine Treating With AIDS Patients (ESATA)

Guangzhou Medical University

Status: Enrolling

Conditions: HIV/AIDS

Treatments: Drug: Ainuovirine

Study type: Observational

Funder types: Other

Identifiers

NCT05420246

X220314682

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnosis of HIV infection 18-60 years old Patients who are prescribed to take Ainuovirine regimen . Sign informed consent

Exclusion criteria

1. Patients who are participating in other interventional clinical trials;
2. Patients who previously participated in the ACC007 study.

Trial design

450 participants in 1 patient group

These cases were given the treatment regimen including Ainuovirine

Description:

These cases were given the regimen including Ainuovirine (150mg, oral,qd)

Treatment:

Drug: Ainuovirine