NCT04592315 is a Phase 1 clinical trial of Lipovirtide Injection in HIV Infections, sponsored by Shanxi Kangbao Biological Product Co., Ltd..

Who is sponsoring NCT04592315?

NCT04592315 is sponsored by Shanxi Kangbao Biological Product Co., Ltd..

What drugs are being tested in NCT04592315?

Interventions in NCT04592315: Lipovirtide Injection.

What condition does NCT04592315 study?

NCT04592315 studies HIV Infections.

Is NCT04592315 still recruiting?

NCT04592315 is currently completed. Last updated 21 September 2023.

Last reviewed 2023-09-21 · How we verify

NCT04592315

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients

Completed Phase 1 Last updated 21 September 2023

What this trial tests

Phase 1 trial testing Lipovirtide Injection in HIV Infections in 46 participants. Completed in 11 July 2023.

Timeline

23 January 2021

Primary endpoint
2 May 2023

11 July 2023

Quick facts

Lead sponsor	Shanxi Kangbao Biological Product Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	23 January 2021
Primary completion	2 May 2023
Estimated completion	11 July 2023
Sites	1 location across China

Drugs / interventions tested

Lipovirtide Injection — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

Shanxi Kangbao Biological Product Co., Ltd. — full company profile →

Who can join

Adults 18 to 60, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

SARS-CoV-2-derived fusion inhibitor lipopeptides exhibit highly potent and broad-spectrum activity against divergent human coronaviruses.
Zhu Y, Yu D, Hu Y, Wu T, et al · · 2021 · cited 28× · PMID 34344868 · DOI 10.1038/s41392-021-00698-x
Structure-based design and characterization of novel fusion-inhibitory lipopeptides against SARS-CoV-2 and emerging variants.
Yu D, Zhu Y, Jiao T, Wu T, et al · · 2021 · cited 26× · PMID 34057039 · DOI 10.1080/22221751.2021.1937329
Antiretroviral Treatment of HIV-2 Infection: Available Drugs, Resistance Pathways, and Promising New Compounds.
Moranguinho I, Taveira N, Bártolo I. · · 2023 · cited 23× · PMID 36982978 · DOI 10.3390/ijms24065905
Pan-coronavirus fusion inhibitors possess potent inhibitory activity against HIV-1, HIV-2, and simian immunodeficiency virus.
Yu D, Zhu Y, Yan H, Wu T, et al · · 2021 · cited 18× · PMID 33847245 · DOI 10.1080/22221751.2021.1917309

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other Shanxi Kangbao Biological Product Co., Ltd. trials

Trials by the same sponsor.

NCT07433387 — Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals · Phase 1, PHASE2 · recruiting
NCT06560489 — Pharmacokinetics and Efficacy of Multiple Dosing of LP-98 for Injection in HIV-infected Patients · Phase 1, PHASE2 · completed
NCT06061536 — Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients. · Phase 2 · completed
NCT05933824 — Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LP-98 Injection in Healthy Subjects · Phase 1 · completed
NCT05349968 — Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04592315 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanxi Kangbao Biological Product Co., Ltd.
Last refreshed: 21 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04592315.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing