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

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Treatments: Anti-Retroviral Agents

Criteria

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.