NCT06061536

Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Shanxi Kangbao Biological Product Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

multiple sites, randomized, open-label, controlled study design. 64 eligible subjects will be enrolled in this study, and they will be randomly assigned to each group in a 1:1:1:1 proportion, 16 subjects in each group. Each site will compete to enroll subjects. The 4 groups are as follows： Group A：Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group B：Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group C：Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）； Group D：DTG +3TC + TDF（once daily）.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Lipovirtide 10mg	Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；
DRUG	Lipovirtide 40mg	Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；
DRUG	Lipovirtide 60mg	Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）；
DRUG	DTG	DTG +3TC + TDF（once daily）.

Timeline

• Start date: 2023-11-02
• Primary completion: 2024-11-29
• Completion: 2025-01-24
• First posted: 2023-09-29
• Last updated: 2026-02-09

Locations

1 site across 1 country: China