Effect of Lipovirtide with Nucleoside Drugs on HIV 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.

This study is testing if a new treatment called Lipovirtide, combined with standard HIV medications, can help people with HIV who haven't had antiviral treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanxi Kangbao Biological Product Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06061536 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled, open-label study designed to evaluate the effectiveness and safety of Lipovirtide in combination with nucleoside drugs for HIV-infected patients who have not previously received antiviral treatment. The study will enroll 64 participants, who will be randomly assigned to one of four treatment groups, each receiving different dosages of Lipovirtide along with standard nucleoside drugs. The primary goal is to assess how well these combinations work in managing HIV infection. The study will take place across multiple sites, with each site competing to enroll eligible subjects.

Who should consider this trial

Good fit: Ideal candidates for this study are untreated adults aged 18 and older who are confirmed to be HIV-1 infected with a viral load of at least 1000 copies/mL.

Not a fit: Patients with severe opportunistic infections, confirmed AIDS, or those who are allergic to any components of the investigational drug may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for HIV-infected patients who have not yet received antiviral therapy.

How similar studies have performed: Other studies have shown promise in using novel combinations of antiviral therapies for HIV, but the specific combination of Lipovirtide with nucleoside drugs is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. age≥18 years (including the critical value) when signed the informed consent form ,.male or female.
2. Untreated, confirmed HIV-1 infected patients;
3. HIV RNA viral load≥1000 copies/mL；
4. CD4+ T cell counts≥200 cells/mm3；
5. 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;
6. 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.

Exclusion Criteria:

1. Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug;
2. Subjects with severe opportunistic infections or opportunistic tumors;
3. Subjects with confirmed AIDS or in the acute infection stage;
4. Hepatitis B virus surface antigen (HBsAg)/hepatitis C virus antibody (HCV-Ab) Positive;
5. ALT and/or AST≥5×ULN；
6. ALT≥3×ULN and total bilirubin≥2×ULN (direct bilirubin/total bilirubin\>35%;
7. GFR\<70ml/min/1.73m2 (estimated from creatinine values based on the CKD-EPI Creatinine 2009 Equation), or creatinine ≥ULN;
8. Subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases;
9. Subjects with a pancreatitis disease history ever before;
10. Subjects who are pregnant or lactating women;
11. Subjects with a history of drug abuse, alcoholism, or substance misuse;
12. 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.

Where this trial is running

Tianjin, Tianjin

• Tianjin Second People's Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Ping Ma, Doctor

Conditions HIV; Lipovirtide; nucleoside drugs