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
Overview
- Phase
- Phase 2
- Intervention
- ASC22 1mg/kg
- Conditions
- HIV-1-infection
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- CD4/CD8 ratio changes compared with baseline
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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.
Arms & Interventions
ASC22 1mg/kg
ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks
Intervention: ASC22 1mg/kg
ASC22 1mg/kg
ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks
Intervention: Antiretroviral Therapy
ASC22 2.5mg/kg
ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks
Intervention: ASC22 2.5mg/kg
ASC22 2.5mg/kg
ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks
Intervention: Antiretroviral Therapy
Placebo
0.9% Saline and anti-retroviral therapy for 12 weeks
Intervention: Antiretroviral Therapy
Placebo
0.9% Saline and anti-retroviral therapy for 12 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
CD4/CD8 ratio changes compared with baseline
Time Frame: Week 4\Week 8\Week 12
Secondary Outcomes
- 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)