Clinical trial NCT05420246: Efficacy and Safety of Ainuovirine Treating With AIDS Patients
Official title: The Efficacy and Safety of Ainuovirine in the Treatment of HIV-infected/AIDS Patients in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV/AIDS
Keywords: Ainuovirine Therapy;Real World Study;HIV-1-infected patients
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Virus suppression rate
timeFrame: 48 weeks
measure: Adverse events
timeFrame: 48 weeks
Secondary outcomes:
measure: Immune reconstitution indicators
timeFrame: 48 weeks
measure: Drug compliance
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou 8th People's Hospital, Guangzhou Medical University.
state: Guangdong
Study officials:
affiliation: Guangzhou Eighth People's Hospital
name: Ruosu Ying, Doctor
role: STUDY_DIRECTOR
References: