Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV

NCT ID: NCT05330143

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2024-05-15

Brief Summary

This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.

Conditions

HIV-1-infection; HIV Infections; PD-L1 Gene Mutation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ASC22 1mg/kg

ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks

Group Type: EXPERIMENTAL

ASC22 1mg/kg

Intervention Type: DRUG

ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.

Antiretroviral Therapy

Intervention Type: DRUG

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

ASC22 2.5mg/kg

ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks

Group Type: EXPERIMENTAL

ASC22 2.5mg/kg

Intervention Type: DRUG

ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.

Antiretroviral Therapy

Intervention Type: DRUG

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

Placebo

0.9% Saline and anti-retroviral therapy for 12 weeks

Group Type: PLACEBO_COMPARATOR

Antiretroviral Therapy

Intervention Type: DRUG

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

Placebo

Intervention Type: DRUG

0.9% saline vials administered subcutaneously once 4 week.

Interventions

ASC22 1mg/kg

ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.

Intervention Type: DRUG

ASC22 2.5mg/kg

ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.

Intervention Type: DRUG

Antiretroviral Therapy

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

Intervention Type: DRUG

Placebo

0.9% saline vials administered subcutaneously once 4 week.

Intervention Type: DRUG

Other Intervention Names

KN035; KN035

Eligibility Criteria

Inclusion Criteria

• Age ≥18 and ≤ 60 years old at screening.
• Treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of HIV-1 infection.
• Treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening.
• CD4+ Cell count ≥300 cells/μL and CD4+/ CD8+ratio ≤ 0.9 at screening.
• Weight ≥ 50 kg at screening.

Exclusion Criteria

• Known allergy to the drug or excipients used in this trial.
• HIV-associated opportunistic infections in the past 5 years.
• Co-sensors of HBV, HCV, syphilis, etc.
• With bleeding disorders or on anticoagulant therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fifth Medical Center of the General Hospital of the Peoples Liberation Army

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ASC22-204

Identifier Type: -

Identifier Source: org_study_id