NCT05420246

Efficacy and Safety of Ainuovirine Treating With AIDS Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Guangzhou 8th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
DRUG	Ainuovirine	The regimen including Ainuovirine will be given to HIV-1 infected/AIDS patients.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2022-06-15
• Last updated: 2022-06-15

Locations

1 site across 1 country: China