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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05330143

Enrollment

Registered

2022-04-15

Start date

2022-06-28

Completion date

2024-05-15

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection, HIV Infections, PD-L1 Gene Mutation

Keywords

ASC22, HIV, PD-L1

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.

Interventions

DRUGASC22 1mg/kg

ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.

DRUGASC22 2.5mg/kg

ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.

DRUGAntiretroviral Therapy

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

DRUGPlacebo

0.9% saline vials administered subcutaneously once 4 week.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
CD4/CD8 ratio changes compared with baseline	Week 4\Week 8\Week 12

Secondary

Measure	Time frame
CD4+ count changes compared with baseline	Week 12
CD8+ count changes compared with baseline	Week 12
HIV-DNA copy changes compared with baselnie	Week 12
CD38 count changes compared with baseline	Week 12
IL-2 concentration changes compared with baseline	Week 4\Week 8\Week 12
HLA-DR number changes compared with baseline	Week 12

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026