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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Second People's Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.