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

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

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.

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.