HIV-1-infectionPhase 2HIV-1NCT04404049
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
A Phase 2 study testing UB-421(25 mg/kg) Q2W and UB-421(25 mg/kg) Q4W in people with HIV-1-infection, run by UBP Greater China (Shanghai) Co., Ltd.
Trial summary
This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- UB-421(25 mg/kg) Q2W and UB-421(25 mg/kg) Q4W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Jun 2025
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 sero-positive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- HIV-1 plasma RNA level below 50 RNA copies/mL.
Who cannot join
- Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
- Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
- Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
- History of anaphylaxis to other mAbs.
- Any vaccination within 8 weeks prior to the first dose of assigned drug.
- Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
About this study
Official title: The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.
- Conditions
- HIV-1-infection
- Being tested
- UB-421(25 mg/kg) Q2W, UB-421(25 mg/kg) Q4W
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-421(25 mg/kg) Q2WBiological
Monoclonal antibody by IV infusion plus standard ART
UB-421(25 mg/kg) Q4WBiological
Monoclonal antibody by IV infusion plus standard ART
| Study group | Role | What they receive |
|---|---|---|
| Standard ART | No intervention | Subjects will receive standard ART for 48 weeks |
| UB-421(25mg/kg) Q2W add-on treatment | Experimental | UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks Receives: Biological: UB-421(25 mg/kg) Q2W |
| UB-421(25mg/kg) Q4W add-on treatment | Experimental | UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks Receives: Biological: UB-421(25 mg/kg) Q4W |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment related TEAEs
the incidence of Grade 3 drug-related treatment-emergent adverse events
Measured: 48Weeks
Secondary outcomes (1)
the change of immune profiles
Change in Treg percentage in the peripheral blood
Measured: 16Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UBP Greater China (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404049
- Sponsor's protocol ID
- UBP-A218-HIV
- Acronym
- HIV-1
- Status last verified
- May 2022
- First submitted
- 21 May 2020
- Last updated
- 18 May 2022
- 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 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
- ClinicalTrials.gov ID
- NCT04404049
- Acronym / sponsor ID
- HIV-1 / UBP-A218-HIV
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- UBP Greater China (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 May 2020 (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 is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard ART | No intervention | –Subjects will receive standard ART for 48 weeks |
| UB-421(25mg/kg) Q2W add-on treatment | Experimental | Biological: UB-421(25 mg/kg) Q2WUB-421(25 mg/kg) Q2W plus standard ART for 48 weeks |
| UB-421(25mg/kg) Q4W add-on treatment | Experimental | Biological: UB-421(25 mg/kg) Q4WUB-421(25 mg/kg) Q4W plus standard ART for 48 weeks |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-1 sero-positive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- HIV-1 plasma RNA level below 50 RNA copies/mL.
Key exclusion criteria (7 listed)
- Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
- Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
- Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
- History of anaphylaxis to other mAbs.
- Any vaccination within 8 weeks prior to the first dose of assigned drug.
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-421(25 mg/kg) Q2WMonoclonal antibody by IV infusion plus standard ART | Biological | UB-421(25mg/kg) Q2W add-on treatment |
| UB-421(25 mg/kg) Q4WMonoclonal antibody by IV infusion plus standard ART | Biological | UB-421(25mg/kg) Q4W add-on treatment |
Primary outcome
treatment related TEAEs
Time frame: 48Weeks
the incidence of Grade 3 drug-related treatment-emergent adverse events
1 secondary outcome
the change of immune profiles
Time frame: 16Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UB-421(25 mg/kg) Q2W and UB-421(25 mg/kg) Q4W 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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?
Results are not available in the source record.
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?
treatment related TEAEs (time frame: 48Weeks). 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 18 May 2022.