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

Ascletis

Status and phase: Completed; Phase 2

Conditions: HIV-1-infection; PD-L1 Gene Mutation; HIV Infections

Treatments: Drug: Antiretroviral Therapy; Drug: Placebo; Drug: ASC22 1mg/kg; Drug: ASC22 2.5mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05330143

ASC22-204

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 3 patient groups, including a placebo group

ASC22 1mg/kg

Experimental group

Description:

ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks

Treatment:

Drug: ASC22 1mg/kg

Drug: Antiretroviral Therapy

ASC22 2.5mg/kg

Experimental group

Description:

ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks

Treatment:

Drug: ASC22 2.5mg/kg

Drug: Antiretroviral Therapy

Placebo

Placebo Comparator group

Description:

0.9% Saline and anti-retroviral therapy for 12 weeks

Treatment:

Drug: Placebo

Drug: Antiretroviral Therapy