HIV-1-infectionPhase 2NCT04985890
A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir
A Phase 2 study testing UB-421 and UB-421+chidamide in people with HIV-1-infection, run by UBP Greater China (Shanghai) Co., Ltd.
Trial summary
To assess the impact of UB-421 and chidamide in changing HIV-1 viral reservoir profile among HIV-1 suppressed patients who undergo short-term ART interruption. To evaluate the safety and tolerability of UB-421 combined with chidamide among HIV-1 suppressed patients who undergo short-term ART interruption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- UB-421 and UB-421+chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible to be included in the study only if ALL of the following criteria apply:
- HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history.
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 18 years or older.
- Have been receiving at least (≧) 2 nucleoside/ nucleotide reverse transcriptase inhibitors (NRTI) plus one non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI, either boosted or un-boosted), integrase strand transfer inhibitor (INSTI) or entry inhibitor (EI) for more than 1 years.
- Have more than 2 different alternative options of optimized ART regimen.
- HIV-1 plasma viral load (VL) level well suppressed below 50 RNA copies/mL for at least (≧) 12 months.
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- No breastfeeding or pregnancy for women.
- Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (eg, barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectable, combinational oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test.
- Subjects must sign the informed consent before undergoing any study procedures.
Who cannot join
- Subjects meeting ANY of the following criteria will be excluded from the study:
- Subjects with active systemic infections, except for HIV-1, that the investigator feels the infections may confound evaluation and treatment for HIV-1.
- Any acquired AIDS-defining illness such as non-Hodgkin's lymphoma or Kaposi's sarcoma according to the U.S. Centers for Disease Control and Prevention Classification System for HIV-1 Infection within the past 12 months .
- Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks .
- Any exposure to a monoclonal antibody within the past 12 weeks.
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, that, in the Investigator's opinion, would preclude the subject from well participation or confound the assessment of study objectives.
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- Current receiving treatment regimen for Diabetes, hepatitis B, hepatitis C, or latent tuberculosis.
- History of anaphylaxis to any monoclonal antibodies or HDAC inhibitor agents.
- Received blood transfusion or hematopoietic growth factor treatment, any vaccine, or a compound with HDAC inhibitor activity (such as valproic acid) recently.
- Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to V1.
- More than one change of ART regimen because of the inability to achieve or maintain suppression of viral replication to an HIV-1 RNA level < 200 copies/mL within the past 12 months
- Receipt of any other investigational study agent(s) within 90 days.
- Experienced urticaria in recent 6 months or ongoing or unresolved skin problems with rash-like symptoms .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Proof of Concept Study to Evaluate the Safety and Efficacy of UB-421 in Combination With Chidamide for Reduction of HIV Reservoir as Compared to UB-421 Alone in ART Stabilized HIV-1 Patients Who Undergo ART Interruption
- To assess the impact of UB-421 and chidamide in changing HIV-1 viral reservoir profile among HIV-1 suppressed patients who undergo short-term ART interruption.
- To evaluate the safety and tolerability of UB-421 combined with chidamide among HIV-1 suppressed patients who undergo short-term ART interruption.
- Conditions
- HIV-1-infection
- Being tested
- UB-421, UB-421+chidamide
- Keywords
- UB-421, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-421Biological
10mg/kg weekly intravenous infusion to substitute for for antiretroviral therapy
UB-421+chidamideOther
10 mg/kg UB-421 weekly intravenous infusion to substitute for antiretroviral therapy, and combined with oral 10 mg chidamide twice a week for 8 weeks. Chidamide taken on the one day and three days after the administration of UB-421.
| Study group | Role | What they receive |
|---|---|---|
| UB-421 monotherapy | Experimental | Subjects will receive 10 mg/kg UB-421 weekly infusion for 8 weeks. Receives: Biological: UB-421 |
| UB-421 + chidamide combination therapy | Experimental | Subjects will receive 10 mg/kg UB-421 weekly infusion and 10 mg chidamide twice a week administration for 8weeks. Receives: Other: UB-421+chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 Total DNA levels
The change in HIV-1 Total DNA from baseline after the study drug administration.
Measured: Post-treatment weeks up to 48 weeks
Secondary outcomes (4)
HIV-1 Total DNA levels
The changes in HIV-1 Total DNA levels during the study
Measured: Post-treatment weeks up to 48 weeks
Treatment related TEAE
The incidence of Grade 3 or higher grade drug-related treatment-emergent adverse events (TEAE)
Measured: through study completion, an average of 0.5 year
Viral suppression
Descriptive analysis of loss of viral suppression (HIV-1 VL> 50 copies/ml) during the study period.
Measured: Post-treatment weeks up to 48 weeks
The number of adverse subjects
The number of adverse subjects leading to discontinuation of UB 421 or Chidamide.
Measured: Post-treatment weeks up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study startMar 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UBP Greater China (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- undergoing undergoing, MD, Study chair, undergoing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985890
- Sponsor's protocol ID
- UBP-A230-HIV
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2021
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Safety and Efficacy of UB-421 in Combination With Chidamide for Reduction of HIV Reservoir as Compared to UB-421 Alone in ART Stabilized HIV-1 Patients Who Undergo ART Interruption
- ClinicalTrials.gov ID
- NCT04985890
- Acronym / sponsor ID
- UBP-A230-HIV
- Conditions
- HIV-1-infection
- Keywords
- UB-421, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UBP Greater China (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Aug 2021 (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.
- To assess the impact of UB-421 and chidamide in changing HIV-1 viral reservoir profile among HIV-1 suppressed patients who undergo short-term ART interruption.
- To evaluate the safety and tolerability of UB-421 combined with chidamide among HIV-1 suppressed patients who undergo short-term ART interruption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UB-421 monotherapy | Experimental | Biological: UB-421Subjects will receive 10 mg/kg UB-421 weekly infusion for 8 weeks. |
| UB-421 + chidamide combination therapy | Experimental | Other: UB-421+chidamideSubjects will receive 10 mg/kg UB-421 weekly infusion and 10 mg chidamide twice a week administration for 8weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects are eligible to be included in the study only if ALL of the following criteria apply:
- HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history.
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 18 years or older.
- Have been receiving at least (≧) 2 nucleoside/ nucleotide reverse transcriptase inhibitors (NRTI) plus one non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI, either boosted or un-boosted), integrase strand transfer inhibitor (INSTI) or entry inhibitor (EI) for more than 1 years.
- Have more than 2 different alternative options of optimized ART regimen.
Key exclusion criteria (13 listed)
- Subjects with active systemic infections, except for HIV-1, that the investigator feels the infections may confound evaluation and treatment for HIV-1.
- Any acquired AIDS-defining illness such as non-Hodgkin's lymphoma or Kaposi's sarcoma according to the U.S. Centers for Disease Control and Prevention Classification System for HIV-1 Infection within the past 12 months .
- Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks .
- Any exposure to a monoclonal antibody within the past 12 weeks.
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, that, in the Investigator's opinion, would preclude the subject from well participation or confound the assessment of study objectives.
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 |
|---|---|---|
| UB-42110mg/kg weekly intravenous infusion to substitute for for antiretroviral therapy | Biological | UB-421 monotherapy |
| UB-421+chidamide10 mg/kg UB-421 weekly intravenous infusion to substitute for antiretroviral therapy, and combined with oral 10 mg chidamide twice a week for 8 weeks. Chidamide taken on the one day and three days after the administration of UB-421. | Other | UB-421 + chidamide combination therapy |
Primary outcome
HIV-1 Total DNA levels
Time frame: Post-treatment weeks up to 48 weeks
The change in HIV-1 Total DNA from baseline after the study drug administration.
4 secondary outcomes
HIV-1 Total DNA levels
Time frame: Post-treatment weeks up to 48 weeks
Treatment related TEAE
Time frame: through study completion, an average of 0.5 year
Viral suppression
Time frame: Post-treatment weeks up to 48 weeks
The number of adverse subjects
Time frame: Post-treatment weeks up to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
undergoing undergoing, MD study chair
undergoing
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UB-421 and UB-421+chidamide in people with HIV-1-infection, run by UBP Greater China (Shanghai) Co., Ltd.
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 9 inclusion and 13 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: opening soon, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Shih, MSc (+886 36684800 ext. 3851, linda.shih@unitedbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1 Total DNA levels (time frame: Post-treatment weeks up to 48 weeks). 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 10 May 2023.