Efficacy and Safety of Ainuovirine Treating With AIDS Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Drug: Ainuovirine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of HIV infection 18-60 years old Patients who are prescribed to take Ainuovirine regimen . Sign informed consent Exclusion Criteria: Patients who are participating in other interventional clinical trials; Patients who previously participated in the ACC007 study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| These cases were given the treatment regimen including Ainuovirine<br>These cases were given the regimen including Ainuovirine (150mg, oral,qd) | Drug: Ainuovirine<br>* The regimen including Ainuovirine will be given to HIV-1 infected/AIDS patients.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ainuovirine Therapy;Real World Study;HIV-1-infected patients