Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected… (NCT06061536) | Clinical Trial Compass
CompletedPhase 2
Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.
China64 participantsStarted 2023-11-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. age≥18 years (including the critical value) when signed the informed consent form ,.male or female.
✓. 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.
Exclusion criteria
✕. 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%;
What they're measuring
1
HIV-1 RNA <50 copies/ml
Timeframe: at Day 169 after receiving Lipovirtide administration.