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

November 22, 2024 updated by: Ascletis Pharmaceuticals Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • The Fifth Medical Center of the General Hospital of the Peoples Liberation Army

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASC22 1mg/kg
ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks
Drug: ASC22 1mg/kg
ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.
Other Names:
  • KN035
Drug: Antiretroviral Therapy
standard antiretroviral therapy including Integrase inhibitors (INSTIs)
Experimental: ASC22 2.5mg/kg
ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks
Drug: Antiretroviral Therapy
standard antiretroviral therapy including Integrase inhibitors (INSTIs)
Drug: ASC22 2.5mg/kg
ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.
Other Names:
  • KN035
Placebo Comparator: Placebo
0.9% Saline and anti-retroviral therapy for 12 weeks
Drug: Antiretroviral Therapy
standard antiretroviral therapy including Integrase inhibitors (INSTIs)
Drug: Placebo
0.9% saline vials administered subcutaneously once 4 week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CD4/CD8 ratio changes compared with baseline
Time Frame: Week 4\Week 8\Week 12
Week 4\Week 8\Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC22-204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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