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

G

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

Trial contacts and locations

1

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Central trial contact

Linghua Li, Doctor

Data sourced from clinicaltrials.gov

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