HIV-1 InfectionPhase 2NCT04041362
the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
A Phase 2 study testing UB-421 and Antiretroviral Therapy (ART) in people with HIV-1 Infection, run by United BioPharma.
Trial summary
This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects. 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 and Antiretroviral Therapy (ART)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Mar 2021
- 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 seropositive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- have been receiving antiretroviral therapy (ART) for more than 2 years
Who cannot join
- Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.
- History of anaphylaxis to monoclonal antibodies.
- Any vaccination within 8 weeks prior to the first dose of UB-421.
About this study
Official title: A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.
- Conditions
- HIV-1 Infection
- Being tested
- UB-421, Antiretroviral Therapy (ART)
- Keywords
- HIV, UB-421
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-421Biological
Monoclonal antibody by IV infusion plus standard ART
Antiretroviral Therapy (ART)Other
Standard ART
| Study group | Role | What they receive |
|---|---|---|
| Arm1 (Standard ART) | Active comparator | Standard ART Receives: Other: Antiretroviral Therapy (ART) |
| Arm 2 (ART plus UB-421) | Experimental | ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks Receives: Biological: UB-421; Other: Antiretroviral Therapy (ART) |
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: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study startApr 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: The study will not be submitted to authority for IND application.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041362
- Sponsor's protocol ID
- UBP-A213-HIV
- Status last verified
- Nov 2019
- First submitted
- 31 Jul 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
- ClinicalTrials.gov ID
- NCT04041362
- Acronym / sponsor ID
- UBP-A213-HIV
- Conditions
- HIV-1 Infection
- Keywords
- HIV, UB-421
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study will not be submitted to authority for IND application.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 1 Aug 2019 (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 assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 (Standard ART) | Active comparator | Other: Antiretroviral Therapy (ART)Standard ART |
| Arm 2 (ART plus UB-421) | Experimental | Biological: UB-421, Other: Antiretroviral Therapy (ART)ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 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 seropositive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- have been receiving antiretroviral therapy (ART) for more than 2 years
Key exclusion criteria (4 listed)
- Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.
- History of anaphylaxis to monoclonal antibodies.
- Any vaccination within 8 weeks prior to the first dose of UB-421.
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-421Monoclonal antibody by IV infusion plus standard ART | Biological | Arm 2 (ART plus UB-421) |
| Antiretroviral Therapy (ART)Standard ART | Other | Arm 2 (ART plus UB-421), Arm1 (Standard ART) |
Primary outcome
treatment related TEAEs
Time frame: 16 Weeks
the incidence of Grade 3 drug-related treatment-emergent adverse events
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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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 and Antiretroviral Therapy (ART) in people with HIV-1 Infection, run by United BioPharma.
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 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: withdrawn, as of the sponsor's last update on 21 Feb 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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: 16 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 21 Feb 2020.