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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| These cases were given the treatment regimen including Ainuovirine | These cases were given the regimen including Ainuovirine (150mg, oral,qd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ainuovirine | Drug | The regimen including Ainuovirine will be given to HIV-1 infected/AIDS patients. |
|
| 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 |
| 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 |
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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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linghua Li, Doctor | Contact | 13725297174 | llheliza@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruosu Ying, Doctor | Guangzhou Eighth People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou 8th People's Hospital, Guangzhou Medical University. | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 48 weeks |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |