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Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.

S

Shanxi Kangbao Biological Product

Status and phase

Enrolling
Phase 2

Conditions

HIV

Treatments

Drug: Lipovirtide 60mg
Drug: Lipovirtide 10mg
Drug: DTG
Drug: Lipovirtide 40mg

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT06061536
SXKB-LP-80-201

Details and patient eligibility

About

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.

Full description

multiple sites, randomized, open-label, controlled study design. 64 eligible subjects will be enrolled in this study, and they will be randomly assigned to each group in a 1:1:1:1 proportion, 16 subjects in each group. Each site will compete to enroll subjects.

The 4 groups are as follows: Group A:Lipovirtide 10mg+3TC+TDF(LP-80:once a week;3TC+TDF:once daily); Group B:Lipovirtide 40mg+3TC+TDF(LP-80:once a week;3TC+TDF:once daily); Group C:Lipovirtide 60mg+3TC+TDF(LP-80:once every 2 weeks;3TC+TDF:once daily); Group D:DTG +3TC + TDF(once daily).

Enrollment

64 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 4 patient groups

Group A:Lipovirtide 10mg+3TC+TDF
Experimental group
Description:
Lipovirtide 10mg+3TC+TDF(LP-80:once a week;3TC+TDF:once daily)
Treatment:
Drug: Lipovirtide 10mg
Group B:Lipovirtide 40mg+3TC+TDF
Experimental group
Description:
Lipovirtide 40mg+3TC+TDF(LP-80:once a week;3TC+TDF:once daily)
Treatment:
Drug: Lipovirtide 40mg
Group C:Lipovirtide 60mg+3TC+TDF
Experimental group
Description:
Lipovirtide 60mg+3TC+TDF(LP-80:once every 2 weeks;3TC+TDF:once daily)
Treatment:
Drug: Lipovirtide 60mg
Group D:DTG +3TC + TDF
Experimental group
Description:
DTG +3TC + TDF(once daily)
Treatment:
Drug: DTG

Trial contacts and locations

1

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Central trial contact

Ping Ma, Doctor

Data sourced from clinicaltrials.gov

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