HIV-1 InfectionPhase 3NCT03149211
To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults
A Phase 3 study testing UB-421 and current standard HAART treatment in people with HIV-1 Infection, run by United BioPharma at 1 site in China.
Trial summary
The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption. 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 current standard HAART treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2025
- 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 sero-positive
- Aged 20 years or older
- Were not breastfeeding for women
- Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
- Subjects agree on using birth control barrier (female or male condom) during the entire study period
- Subjects sign the informed consent before undergoing any study procedures
Who cannot join
- Any active infection except for HIV, and required immediate therapy
- Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
- Life expectancy less than 12 months
- Any alcohol or illicit drug used, according to the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100069
About this study
Official title: A Phase III, Randomized, Open-label, Controlled Trial to Investigate the Efficacy and Safety of UB-421 Monotherapy as Substitution for Stable Antiretroviral Therapy in HIV-1 Infected Adults
The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption.
Read the detailed description
This is an open-label, Phase III study to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound while replace HAART in virally suppressed HIV-1 infected adults. In this study, approximately 375 subjects on stable HAART treatment will be randomized to receive either continuing HAART treatment alone (Cohort 1) or UB-421 as the monotherapy (Cohort 2) in 1:2 ratio. For Cohort 1, subjects will receive current standard HAART treatment as the active control group. For Cohort 2, UB-421 will be administered to enrolled subjects without HAART treatment in the Cohort 2 during the 26-week treatment period. After treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period.
- Conditions
- HIV-1 Infection
- Being tested
- UB-421, current standard HAART treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-421Drug
Also called dB4C7 mAb
Subjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks).
current standard HAART treatmentDrug
Subjects will receive current standard HAART treatment as the active control group.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Subjects will receive current standard HAART treatment as the active control group. Receives: Drug: current standard HAART treatment |
| Cohort 2 | Experimental | Subjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment. Receives: Drug: UB-421; Drug: current standard HAART treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants without virologic failure
Measured: 24 weeks
Secondary outcomes (4)
Time to virologic failure
Measured: 26 weeks
Number of participants with treatment-related adverse events
Measured: 48 weeks
Peak concentration of UB-421 in Cohort 2
Measured: 30 weeks
Trough concentration of UB-421 in Cohort 2
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: project adjustment
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
- 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
- NCT03149211
- Sponsor's protocol ID
- UBP-A304-HIV
- Status last verified
- Apr 2023
- First submitted
- 2 May 2017
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-label, Controlled Trial to Investigate the Efficacy and Safety of UB-421 Monotherapy as Substitution for Stable Antiretroviral Therapy in HIV-1 Infected Adults
- ClinicalTrials.gov ID
- NCT03149211
- Acronym / sponsor ID
- UBP-A304-HIV
- Conditions
- HIV-1 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: project adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 May 2017 (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, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption.
Detailed description
This is an open-label, Phase III study to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound while replace HAART in virally suppressed HIV-1 infected adults. In this study, approximately 375 subjects on stable HAART treatment will be randomized to receive either continuing HAART treatment alone (Cohort 1) or UB-421 as the monotherapy (Cohort 2) in 1:2 ratio. For Cohort 1, subjects will receive current standard HAART treatment as the active control group. For Cohort 2, UB-421 will be administered to enrolled subjects without HAART treatment in the Cohort 2 during the 26-week treatment period. After treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: current standard HAART treatmentSubjects will receive current standard HAART treatment as the active control group. |
| Cohort 2 | Experimental | Drug: UB-421, Drug: current standard HAART treatmentSubjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-1 sero-positive
- Aged 20 years or older
- Were not breastfeeding for women
- Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
- Subjects agree on using birth control barrier (female or male condom) during the entire study period
Key exclusion criteria (5 listed)
- Any active infection except for HIV, and required immediate therapy
- Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
- Life expectancy less than 12 months
- Any alcohol or illicit drug used, according to the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
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-421Also: dB4C7 mAbSubjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks). | Drug | Cohort 2 |
| current standard HAART treatmentSubjects will receive current standard HAART treatment as the active control group. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Number of participants without virologic failure
Time frame: 24 weeks
4 secondary outcomes
Time to virologic failure
Time frame: 26 weeks
Number of participants with treatment-related adverse events
Time frame: 48 weeks
Peak concentration of UB-421 in Cohort 2
Time frame: 30 weeks
Trough concentration of UB-421 in Cohort 2
Time frame: 30 weeks
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 25 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.
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 3 study testing UB-421 and current standard HAART treatment in people with HIV-1 Infection, run by United BioPharma 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 6 inclusion and 5 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 25 Apr 2023. 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. 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?
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?
Number of participants without virologic failure (time frame: 24 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 25 Apr 2023.