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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Drug: Ainuovirine

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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Linghua Li, Doctor; Phone Number: 13725297174; Email: llheliza@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Guangzhou 8th People's Hospital, Guangzhou Medical University.
      • Contact: Ke Yingchun, Master; Phone Number: 020-83803656; Email: keyich@163.com
      • Contact: Li Linghua, PhD; Phone Number: 020-883710825; Email: llheliza@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are prescribed to take including Ainuovirine regimen,because they are unable to tolerate the side-effect of or are not fit for the firstline free regimen in China,according to clinical judgment, no matter of the HIV-RNA viral loads and CD4 cell counts.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
These cases were given the treatment regimen including Ainuovirine; These cases were given the regimen including Ainuovirine (150mg, oral,qd)	Drug: Ainuovirine; The regimen including Ainuovirine will be given to HIV-1 infected/AIDS patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virus suppression rate	ratio of HIV1-RNA < 20 copies/mL at 48 weeks of treatment	48 weeks
Adverse events	Any adverse events reported during the observational period	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune reconstitution indicators	CD4 cell count, CD4 +/ CD8 + ratio (baseline to 48 weeks)	48 weeks
Drug compliance	To explicit the number of people who have completed the treatment	48 weeks

Collaborators and Investigators

• Sponsor: Guangzhou 8th People's Hospital
• Investigators: Study Director: Ruosu Ying, Doctor, Guangzhou Eighth People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (ACTUAL): June 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Ainuovirine Therapy;Real World Study;HIV-1-infected patients
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: X220314682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No