Efficacy and Safety of Ainuovirine Treating With AIDS Patients

NCT05420246 | Unknown

• 1 other identifier: X220314682
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS

Keywords

Ainuovirine Therapy;Real World Study;HIV-1-infected patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Immune reconstitution indicators

  48 weeks

• Drug compliance

  48 weeks

Study Arms (1)

These cases were given the treatment regimen including Ainuovirine

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

Drug: Ainuovirine

Interventions

Ainuovirine DRUG

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

These cases were given the treatment regimen including Ainuovirine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou 8th People's Hospital: lead

Study Sites (1)

Guangzhou 8th People's Hospital, Guangzhou Medical University.

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ruosu Ying, Doctor

  Guangzhou Eighth People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Linghua Li, Doctor

CONTACT

13725297174; llheliza@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 15, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)