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

Phase 2

Completed

• Conditions: HIV-1-infection; HIV Infections; PD-L1 Gene Mutation
• Interventions: Drug: ASC22 1mg/kg; Drug: ASC22 2.5mg/kg; Drug: Antiretroviral Therapy; Drug: Placebo

• Registration Number: NCT05330143
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2022-06-28
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASC22 2.5mg/kg	Antiretroviral Therapy	ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks
Placebo	Antiretroviral Therapy	0.9% Saline and anti-retroviral therapy for 12 weeks
Placebo	Placebo	0.9% Saline and anti-retroviral therapy for 12 weeks
ASC22 1mg/kg	ASC22 1mg/kg	ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks
ASC22 1mg/kg	Antiretroviral Therapy	ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks
ASC22 2.5mg/kg	ASC22 2.5mg/kg	ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks

Primary Outcome Measures

Name	Time	Method
CD4/CD8 ratio changes compared with baseline	Week 4\Week 8\Week 12

Secondary Outcome Measures

Name	Time	Method
HIV-DNA copy changes compared with baselnie	Week 12
IL-2 concentration changes compared with baseline	Week 4\Week 8\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

Trial Locations

Locations (1)

The Fifth Medical Center of the General Hospital of the Peoples Liberation Army; 🇨🇳 Beijing, Beijing, China