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| Name | Class |
|---|---|
| Institute of Pathogen Biology, Beijing, China | OTHER |
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To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose 5 mg |
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| 2 | Experimental | Dose 10 mg |
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| 3 | Experimental | Dose 20 mg |
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| 4 | Experimental | Dose 40 mg |
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| 5 | Experimental | Dose 60 mg |
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| 6 | Experimental | Dose 80 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipovirtide Injection | Drug | Single dosage of Lipovirtide Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events as Assessed by DAIDS v1.0 | Evaluation of safety and tolerability after single dose of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy | Day 1 to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic characteristics- Area Under the Plasma Concentration Versus Time Curve (AUC) | Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters. | Area Under the Plasma Concentration Versus Time Curve (AUC) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haibin Yu, MD | Beijing You'an Hospital, Beijing Medical University | Principal Investigator |
| Hao Wu, MD | Beijing You'an Hospital, Beijing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing You'an Hospital, Beijing Medical University | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Pharmacokinetic characteristics-Peak plasma concentration (Cmax) | Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters. | Peak plasma concentration (Cmax) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose." |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |