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Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients

NCT05349968 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-11

No results posted yet for this study

Summary

Primary Objectives

1.Evaluation of safety and tolerability after repeated administration of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy

Secondary Objectives

1. Evaluation of the pharmacokinetic properties of injectable Lipovirtide after multiple administrations in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.
2. Evaluation of the efficacy of injectable Lipovirtide for HIV in HIV-infected patients not receiving antiretroviral therapy.
3. Evaluation of the immunogenicity of lipovirtide for injection.

Conditions

  • HIV Infections

Interventions

DRUG

Lipovirtide for injection

Multiple dosing of Lipovirtide

Sponsors & Collaborators

  • Institute of Pathogen Biology, Beijing, China

    collaborator OTHER

  • Shanxi Kangbao Biological Product Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Haibin Yu · Beijing You'an Hospital, Beijing Medical University

  • Hao Wu · Beijing You'an Hospital, Beijing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2023-06-07
Completion
2023-09-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05349968 on ClinicalTrials.gov