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

NCT05330143 | Completed Phase 2

• 1 other identifier: ASC22-204
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Keywords

ASC22; HIV; PD-L1

Outcome Measures

Primary Outcomes (1)

• CD4/CD8 ratio changes compared with baseline

  Week 4\Week 8\Week 12

Secondary Outcomes (6)

• HIV-DNA copy changes compared with baselnie

  Week 12

• CD4+ count changes compared with baseline

  Week 12

• CD8+ count changes compared with baseline

  Week 12

• HLA-DR number changes compared with baseline

  Week 12

• CD38 count changes compared with baseline

  Week 12

Study Arms (3)

ASC22 1mg/kg

EXPERIMENTAL

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

Drug: ASC22 1mg/kg; Drug: Antiretroviral Therapy

ASC22 2.5mg/kg

EXPERIMENTAL

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

Drug: ASC22 2.5mg/kg; Drug: Antiretroviral Therapy

Placebo

PLACEBO COMPARATOR

0.9% Saline and anti-retroviral therapy for 12 weeks

Drug: Antiretroviral Therapy; Drug: Placebo

Interventions

ASC22 1mg/kg DRUG

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

Also known as: KN035

ASC22 1mg/kg

ASC22 2.5mg/kg DRUG

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

Also known as: KN035

ASC22 2.5mg/kg

Antiretroviral Therapy DRUG

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

ASC22 1mg/kg; ASC22 2.5mg/kg; Placebo

Placebo DRUG

0.9% saline vials administered subcutaneously once 4 week.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

HIV Infections

Interventions

envafolimab; Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 15, 2022
• Study Start: June 28, 2022
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-10

Locations

CN (1)