NCT06061536

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_2 hiv

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2025

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

September 18, 2023

Last Update Submit

February 5, 2026

Conditions

HIV

Keywords

LipovirtideHIVnucleoside drugs

Outcome Measures

Primary Outcomes (1)

  • HIV-1 RNA <50 copies/ml

    The proportion of subjects with HIV-1 RNA \<50 copies/ml at Day 169 after receiving Lipovirtide administration.

    at Day 169 after receiving Lipovirtide administration.

Secondary Outcomes (43)

  • HIV-1 RNA <50 copies/ml

    at Day 29、Day 85、Day 169 after receiving Lipovirtide administration

  • HIV-1 RNA <400 copies/ml

    at Day 85、Day 169 after receiving Lipovirtide administration

  • CD4+ T-cell and CD8+ T-cell

    at Day 85 and Day 169 after receiving Lipovirtide administration

  • HIV-1 RNA <50 copies/ml

    Within Day 169 of after receiving Lipovirtide administration

  • HIV-1 RNA

    Within Day 169 of after receiving Lipovirtide administration

  • +38 more secondary outcomes

Study Arms (4)

Group A：Lipovirtide 10mg+3TC+TDF

EXPERIMENTAL

Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）

Drug: Lipovirtide 10mg

Group B：Lipovirtide 40mg+3TC+TDF

EXPERIMENTAL

Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）

Drug: Lipovirtide 40mg

Group C：Lipovirtide 60mg+3TC+TDF

EXPERIMENTAL

Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）

Drug: Lipovirtide 60mg

Group D：DTG +3TC + TDF

EXPERIMENTAL

DTG +3TC + TDF（once daily）

Drug: DTG

Interventions

Lipovirtide 40mgDRUG

Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；

Also known as: 3TC, TDF
Group B：Lipovirtide 40mg+3TC+TDF
Lipovirtide 60mgDRUG

Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）；

Also known as: 3TC, TDF
Group C：Lipovirtide 60mg+3TC+TDF
DTGDRUG

DTG +3TC + TDF（once daily）.

Also known as: 3TC, TDF
Group D：DTG +3TC + TDF
Lipovirtide 10mgDRUG

Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；

Also known as: 3TC, TDF
Group A：Lipovirtide 10mg+3TC+TDF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age≥18 years (including the critical value) when signed the informed consent form ,.male or female.
  • Untreated, confirmed HIV-1 infected patients;
  • HIV RNA viral load≥1000 copies/mL；
  • CD4+ T cell counts≥200 cells/mm3；
  • Subjects who have no plans for conception within the 2 weeks prior to screening and 3 months after the end of the trial, and who agree to use effective non-pharmacological contraceptive measures during the trial;
  • Sign informed consent prior to the test and fully understand the purpose, nature, methods, and possible adverse reactions, and be willing to participate in the study.

You may not qualify if:

  • Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug;
  • Subjects with severe opportunistic infections or opportunistic tumors;
  • Subjects with confirmed AIDS or in the acute infection stage;
  • Hepatitis B virus surface antigen (HBsAg)/hepatitis C virus antibody (HCV-Ab) Positive;
  • ALT and/or AST≥5×ULN；
  • ALT≥3×ULN and total bilirubin≥2×ULN (direct bilirubin/total bilirubin\>35%;
  • GFR\<70ml/min/1.73m2 (estimated from creatinine values based on the CKD-EPI Creatinine 2009 Equation), or creatinine ≥ULN;
  • Subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases;
  • Subjects with a pancreatitis disease history ever before;
  • Subjects who are pregnant or lactating women;
  • Subjects with a history of drug abuse, alcoholism, or substance misuse;
  • Any clinical trials in the 3 months prior to the screening of the trial; 13）Subjects may not be able to complete this study or other investigators' judgment for other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

Study Officials

  • Ping Ma, Doctor

    Tianjin Second People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 29, 2023

Study Start

November 2, 2023

Primary Completion

November 29, 2024

Study Completion

January 24, 2025

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)