HIV-1-infectionPhase 2NCT05330143
Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV
A Phase 2 study testing ASC22 1mg/kg, ASC22 2.5mg/kg and Antiretroviral Therapy in people with HIV-1-infection and HIV Infections, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1-infection, HIV Infections, PD-L1 Gene Mutation
- What is being tested?
- ASC22 1mg/kg, ASC22 2.5mg/kg and Antiretroviral Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2022to 15 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The Fifth Medical Center of the General Hospital of the Peoples Liberation Army
Beijing, Beijing Municipality, 100071
About this study
Official 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
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.
- Conditions
- HIV-1-infection, HIV Infections, PD-L1 Gene Mutation
- Being tested
- ASC22 1mg/kg, ASC22 2.5mg/kg, Antiretroviral Therapy, Placebo
- Keywords
- ASC22, HIV, PD-L1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC22 1mg/kgDrug
Also called KN035
ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.
ASC22 2.5mg/kgDrug
Also called KN035
ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.
Antiretroviral TherapyDrug
standard antiretroviral therapy including Integrase inhibitors (INSTIs)
PlaceboDrug
0.9% saline vials administered subcutaneously once 4 week.
| Study group | Role | What they receive |
|---|---|---|
| ASC22 1mg/kg | Experimental | ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks Receives: Drug: ASC22 1mg/kg; Drug: Antiretroviral Therapy |
| ASC22 2.5mg/kg | Experimental | ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks Receives: Drug: ASC22 2.5mg/kg; Drug: Antiretroviral Therapy |
| Placebo | Placebo comparator | 0.9% Saline and anti-retroviral therapy for 12 weeks Receives: Drug: Antiretroviral Therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4/CD8 ratio changes compared with baseline
Measured: Week 4\Week 8\Week 12
Secondary outcomes (6)
HIV-DNA copy changes compared with baselnie
Measured: Week 12
CD4+ count changes compared with baseline
Measured: Week 12
CD8+ count changes compared with baseline
Measured: Week 12
HLA-DR number changes compared with baseline
Measured: Week 12
CD38 count changes compared with baseline
Measured: Week 12
IL-2 concentration changes compared with baseline
Measured: Week 4\Week 8\Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start28 Jun 2022
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330143
- Sponsor's protocol ID
- ASC22-204
- Status last verified
- Oct 2024
- First submitted
- 17 Mar 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05330143
- Acronym / sponsor ID
- ASC22-204
- Conditions
- HIV-1-infection, HIV Infections, PD-L1 Gene Mutation
- Keywords
- ASC22, HIV, PD-L1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASC22 1mg/kg | Experimental | Drug: ASC22 1mg/kg, Drug: Antiretroviral TherapyASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks |
| ASC22 2.5mg/kg | Experimental | Drug: ASC22 2.5mg/kg, Drug: Antiretroviral TherapyASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks |
| Placebo | Placebo comparator | Drug: Antiretroviral Therapy, Drug: Placebo0.9% Saline and anti-retroviral therapy for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC22 1mg/kgAlso: KN035ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week. | Drug | ASC22 1mg/kg |
| ASC22 2.5mg/kgAlso: KN035ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week. | Drug | ASC22 2.5mg/kg |
| Antiretroviral Therapystandard antiretroviral therapy including Integrase inhibitors (INSTIs) | Drug | ASC22 1mg/kg, ASC22 2.5mg/kg, Placebo |
| Placebo0.9% saline vials administered subcutaneously once 4 week. | Drug | Placebo |
Primary outcome
CD4/CD8 ratio changes compared with baseline
Time frame: Week 4\Week 8\Week 12
6 secondary outcomes
HIV-DNA copy changes compared with baselnie
Time frame: Week 12
CD4+ count changes compared with baseline
Time frame: Week 12
CD8+ count changes compared with baseline
Time frame: Week 12
HLA-DR number changes compared with baseline
Time frame: Week 12
CD38 count changes compared with baseline
Time frame: Week 12
IL-2 concentration changes compared with baseline
Time frame: Week 4\Week 8\Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC22 1mg/kg, ASC22 2.5mg/kg and Antiretroviral Therapy in people with HIV-1-infection and HIV Infections, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4/CD8 ratio changes compared with baseline (time frame: Week 4\Week 8\Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.