HIV-1 InfectionPhase 3NCT04406727
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
A Phase 3 study testing UB-421 and Antiretroviral (ARV) in people with HIV-1 Infection, run by United BioPharma.
Trial summary
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- UB-421 and Antiretroviral (ARV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Jun 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 seropositive
- Have a history of at least 6 months on antiretroviral treatment
- Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening
Who cannot join
- Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)
- Females who are pregnant
- Any vaccination within 2 weeks prior to the Screening
- Any prior exposure to UB-421
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.
- Conditions
- HIV-1 Infection
- Being tested
- UB-421, Antiretroviral (ARV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-421Biological
UB-421 in combination with their ARV
Antiretroviral (ARV)Other
Antiretroviral (ARV)
| Study group | Role | What they receive |
|---|---|---|
| UB-421 | Experimental | 2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV
Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR). Receives: Biological: UB-421; Other: Antiretroviral (ARV) |
| Placebo | Active comparator | 2-arm Comparison Phase: Placebo in combination with ARV
Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR). Receives: Other: Antiretroviral (ARV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV-1 RNA viral load between 2 arms
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406727
- Sponsor's protocol ID
- UBP-A308-HIV
- Status last verified
- Apr 2023
- First submitted
- 22 May 2020
- Last updated
- 24 Apr 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
- ClinicalTrials.gov ID
- NCT04406727
- Acronym / sponsor ID
- UBP-A308-HIV
- Conditions
- HIV-1 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 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.
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UB-421 | Experimental | Biological: UB-421, Other: Antiretroviral (ARV)2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR). |
| Placebo | Active comparator | Other: Antiretroviral (ARV)2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-1 seropositive
- Have a history of at least 6 months on antiretroviral treatment
- Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening
Key exclusion criteria (4 listed)
- Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)
- Females who are pregnant
- Any vaccination within 2 weeks prior to the Screening
- Any prior exposure to 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-421UB-421 in combination with their ARV | Biological | UB-421 |
| Antiretroviral (ARV)Antiretroviral (ARV) | Other | Placebo, UB-421 |
Primary outcome
Change in HIV-1 RNA viral load between 2 arms
Time frame: 14 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UB-421 and Antiretroviral (ARV) 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: status not confirmed, as of the sponsor's last update on 24 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Linda Shih (+886-3-668-4800 ext. 3204, linda.shih@unitedbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV-1 RNA viral load between 2 arms (time frame: 14 Days). 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 24 Apr 2023.