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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
19
ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.
ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.
standard antiretroviral therapy including Integrase inhibitors (INSTIs)
The Fifth Medical Center of the General Hospital of the Peoples Liberation Army
Beijing, Beijing Municipality, China
CD4/CD8 ratio changes compared with baseline
Time frame: Week 4\Week 8\Week 12
HIV-DNA copy changes compared with baselnie
Time frame: Week 12
CD4+ count changes compared with baseline
Time frame: Week 12
CD8+ count changes compared with baseline
Time frame: Week 12
HLA-DR number changes compared with baseline
Time frame: Week 12
CD38 count changes compared with baseline
Time frame: Week 12
IL-2 concentration changes compared with baseline
Time frame: Week 4\Week 8\Week 12
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0.9% saline vials administered subcutaneously once 4 week.