A Randomized, Controlled, Open-label, Dose-exploration Study to Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients Who Have Not Received Antiviral Treatment Before.

A randomized, controlled, open-label, dose-exploration study to assess the effectiveness and safety of Lipovirtide combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment before.

Start Date02 Nov 2023

Sponsor / Collaborator

Shanxi Kangbao Biological Product Co. Ltd.

[+1]

CTR20233018 / RecruitingPhase 2

评价注射用利普韦肽联合核苷药物在未接受过抗病毒治疗的HIV 感染者中的有效性、安全性的随机、对照、开放、剂量探索临床研究

[Translation] A randomized, controlled, open, dose-finding clinical study to evaluate the efficacy and safety of lepviride for injection combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment

评价注射用利普韦肽联合核苷药物在未接受过抗病毒治疗的HIV 感染者中的有效性、安全性的随机、对照、开放、剂量探索临床研究

[Translation]

A randomized, controlled, open, dose-finding clinical study to evaluate the efficacy and safety of lepviride for injection combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment

Start Date02 Nov 2023

Sponsor / Collaborator

Institute of Pathogen Biology Chinese Academy of Medical Sciences

[+1]

CTR20220714 / CompletedPhase 1

评价注射用利普韦肽对未接受过抗病毒治疗HIV感染者多次给药安全性、药代动力学及疗效的临床研究

[Translation] A clinical study to evaluate the safety, pharmacokinetics and efficacy of multiple doses of lepviride for injection in HIV-infected patients who have not received antiviral treatment

主要目的 1.评价未接受过抗病毒治疗的HIV感染者多次给予注射用利普韦肽后的安全性和耐受性。次要目的 1.评价未接受过抗病毒治疗的HIV感染者多次给予注射用利普韦肽后的药代动力学特性，获取药代动力学参数。 2.评价注射用利普韦肽在未接受过抗病毒治疗的HIV感染者中的抗HIV疗效。评价注射用利普韦肽的免疫原性。

[Translation]

Main purpose 1. To evaluate the safety and tolerability of multiple administrations of Lepvirtide for injection in HIV-infected patients who have not received antiviral treatment. Secondary purpose 1. To evaluate the pharmacokinetic properties of Lepvirtide for injection in HIV-infected patients who have not received antiviral treatment and obtain pharmacokinetic parameters. 2. To evaluate the anti-HIV efficacy of Lepvirtide for injection in HIV-infected patients who have not received antiviral treatment. To evaluate the immunogenicity of Lepvirtide for injection.

Start Date10 Jun 2022

Sponsor / Collaborator

Institute of Pathogen Biology Chinese Academy of Medical Sciences

[+1]

100 Clinical Results associated with Lipovirtide

100 Translational Medicine associated with Lipovirtide

100 Patents (Medical) associated with Lipovirtide

100 Deals associated with Lipovirtide

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	CN	Institute of Pathogen Biology Chinese Academy of Medical Sciences	02 Nov 2023
HIV Infections	Phase 2	CN	Shanxi Kangbao Biological Product Co. Ltd.	02 Nov 2023

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