HIV-1 InfectionPhase 2NCT05056974
A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs
A Phase 2 study testing UB-421 and chidamide in people with HIV-1 Infection, run by United BioPharma at 1 site in Taiwan.
Trial summary
This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART 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 chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Dec 2021to 1 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 20 years or older.
- No breastfeeding or pregnancy for women.
- Have been receiving ART for more than 3 years by screening visit 1 (SV1).
- Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
- Subjects must sign the informed consent before undergoing any study procedures.
Who cannot join
- Subjects with active systemic infections, except for HIV-1
- Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
- Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
- Any alcohol or illicit drug use
- Receipt of any other investigational study agent(s) within 90 days before SV2.
- Currently on the treatment for diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs Among ART Stabilized HIV-1 Patients Who Undergo ART Interruption
This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.
- Conditions
- HIV-1 Infection
- Being tested
- UB-421, chidamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-421Biological
10 mg/kg, weekly UB-421 during the 8-week
chidamideDrug
10 mg/dose, twice a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| UB-421 + chidamide | Experimental | UB-421 + chidamide combination therapy Receives: Biological: UB-421; Drug: chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV cell-associated RNA levels
The change in HIV-1 Total DNA from baseline after study drug administration.
Measured: Post-treatment weeks up to 48 weeks
Secondary outcomes (1)
HIV-1 Total DNA levels
The changes in HIV-1 Total DNA levels during the study
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 posted27 Sep 2021
- Study start2 Dec 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT05056974
- Sponsor's protocol ID
- UBP-A232-HIV
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2021
- Last updated
- 15 Feb 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs Among ART Stabilized HIV-1 Patients Who Undergo ART Interruption
- ClinicalTrials.gov ID
- NCT05056974
- Acronym / sponsor ID
- UBP-A232-HIV
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 27 Sep 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.
This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UB-421 + chidamide | Experimental | Biological: UB-421, Drug: chidamideUB-421 + chidamide combination therapy |
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, with documented HIV-1 infection by official, signed, written history
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
- No breastfeeding or pregnancy for women.
- Have been receiving ART for more than 3 years by screening visit 1 (SV1).
- Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
Key exclusion criteria (6 listed)
- Subjects with active systemic infections, except for HIV-1
- Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
- Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
- Any alcohol or illicit drug use
- Receipt of any other investigational study agent(s) within 90 days before SV2.
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-42110 mg/kg, weekly UB-421 during the 8-week | Biological | UB-421 + chidamide |
| chidamide10 mg/dose, twice a week for 8 weeks | Drug | UB-421 + chidamide |
Primary outcome
HIV cell-associated RNA levels
Time frame: Post-treatment weeks up to 48 weeks
The change in HIV-1 Total DNA from baseline after study drug administration.
1 secondary outcome
HIV-1 Total DNA levels
Time frame: Post-treatment weeks up to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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 2 study testing UB-421 and chidamide in people with HIV-1 Infection, run by United BioPharma at 1 site in Taiwan.
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 6 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: finished, as of the sponsor's last update on 15 Feb 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 Taiwan. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HIV cell-associated RNA 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 15 Feb 2023.