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NCT06061536CompletedPhase 2

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.

Source: ClinicalTrials.gov · Last updated 13 May 2026

Brief summary (registry, in English)

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 (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
64 (actual)
First submitted
18 Sept 2023
Start date
2 Nov 2023
Primary completion date
29 Nov 2024
Lead sponsor
Shanxi Kangbao Biological Product Co., Ltd.
Diseases
HIV
NCT number
NCT06061536

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 64
  • From 2 Nov 2023 to the primary completion date, 29 Nov 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug;
  • 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.

Other illness

  • 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;
  • Subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases;
  • Subjects with a pancreatitis disease history ever before;
  • Subjects with a history of drug abuse, alcoholism, or substance misuse;

Lab values

  • 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;

Other

  • Subjects who are pregnant or lactating women;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tianjin Second People's Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.