Efficacy and Safety of Ainuovirine Treating With AIDS Patients

HIV/AIDS Clinical Trial

— ESATA  

Official title:

The Efficacy and Safety of Ainuovirine in the Treatment of HIV-infected/AIDS Patients in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420246
• Other study ID #: X220314682
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2022
• Source: Guangzhou 8th People's Hospital
• Contact: Linghua Li, Doctor
• Phone: 13725297174
• Email: llheliza[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Drug:
• Ainuovirine
The regimen including Ainuovirine will be given to HIV-1 infected/AIDS patients.

Locations

Country	Name	City	State
China	Guangzhou 8th People's Hospital, Guangzhou Medical University.	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou 8th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virus suppression rate	ratio of HIV1-RNA < 20 copies/mL at 48 weeks of treatment	48 weeks
Primary	Adverse events	Any adverse events reported during the observational period	48 weeks
Secondary	Immune reconstitution indicators	CD4 cell count, CD4 +/ CD8 + ratio (baseline to 48 weeks)	48 weeks
Secondary	Drug compliance	To explicit the number of people who have completed the treatment	48 weeks