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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Multi-center, Randomized,Blind, Placebo-controlled Study to Evaluate Safety,Tolerance and Efficacy of ASC22 Combined With ART in Subjects With Human Immunodeficiency Virus

Conditions
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HIV-1-infection, HIV Infections, PD-L1 Gene Mutation

Intervention / Treatment
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* Drug: ASC22 1mg/kg
* Drug: ASC22 2.5mg/kg
* Drug: Antiretroviral Therapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤ 75 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC22 1mg/kg<br>ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks | Drug: ASC22 1mg/kg<br>* ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.<br>* Other names: KN035;Drug: Antiretroviral Therapy<br>* standard antiretroviral therapy including Integrase inhibitors (INSTIs)<br>|
| Experimental: ASC22 2.5mg/kg<br>ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks | Drug: ASC22 2.5mg/kg<br>* ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.<br>* Other names: KN035;Drug: Antiretroviral Therapy<br>* standard antiretroviral therapy including Integrase inhibitors (INSTIs)<br>|
| Placebo Comparator: Placebo<br>0.9% Saline and anti-retroviral therapy for 12 weeks | Drug: Antiretroviral Therapy<br>* standard antiretroviral therapy including Integrase inhibitors (INSTIs)<br>Drug: Placebo<br>* 0.9% saline vials administered subcutaneously once 4 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4/CD8 ratio changes compared with baseline |  | Week 4\Week 8\Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| IL-2 concentration changes compared with baseline |  | Week 4\Week 8\Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASC22, HIV, PD-L1