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OpenTrials
Completed

NCT Number: NCT05330143

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

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.

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Key information

Conditions

HIV-1-infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections PD-L1 Gene Mutation RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Fifth Medical Center of the General Hospital of the Peoples Liberation Army

Beijing, Beijing Municipality, 100071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC22 1mg/kg

Drug

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

Other names: KN035

ASC22 2.5mg/kg

Drug

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

Other names: KN035

Antiretroviral therapy

Drug

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

Placebo

Drug

0.9% saline vials administered subcutaneously once 4 week.

Primary outcomes

  1. CD4/CD8 ratio changes compared with baseline

    Time frame: Week 4\Week 8\Week 12

Secondary outcomes

  1. HIV-DNA copy changes compared with baselnie

    Time frame: Week 12

  2. CD4+ count changes compared with baseline

    Time frame: Week 12

  3. CD8+ count changes compared with baseline

    Time frame: Week 12

  4. HLA-DR number changes compared with baseline

    Time frame: Week 12

  5. CD38 count changes compared with baseline

    Time frame: Week 12

  6. IL-2 concentration changes compared with baseline

    Time frame: Week 4\Week 8\Week 12

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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