HIV/AIDS
Conditions
Keywords
Ainuovirine Therapy;Real World Study;HIV-1-infected patients
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.
Interventions
DRUGAinuovirine
The regimen including Ainuovirine will be given to HIV-1 infected/AIDS patients.
Sponsors
Guangzhou 8th People's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virus suppression rate | 48 weeks | ratio of HIV1-RNA \< 20 copies/mL at 48 weeks of treatment |
| Adverse events | 48 weeks | Any adverse events reported during the observational period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune reconstitution indicators | 48 weeks | CD4 cell count, CD4 +/ CD8 + ratio (baseline to 48 weeks) |
| Drug compliance | 48 weeks | To explicit the number of people who have completed the treatment |
Countries
China
Contacts
Primary ContactLinghua Li, Doctor
Outcome results
None listed