HIV-1 InfectionPhase 2NCT03164447
UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients
A Phase 2 study testing UB-421 and Optimized background therapy (OBT) in people with HIV-1 Infection, run by United BioPharma.
Trial summary
This is a Phase 2, multi-center study, designed to evaluate the efficacy, safety, and tolerability of UB-421 in conjunction with a failing existing ART regimen for 1 week and optimized background therapy (OBT) for 24 weeks, respectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- UB-421 and Optimized background therapy (OBT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age ≥18 years;
- HIV-1 seropositive, with documented HIV-1 infection by official, signed, written history (eg. Laboratory report);
- Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening and are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
- Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA >200 copies/ml) within the last 3 months prior to the Screening Visit;
- Highly treatment-experienced HIV-infected patients with documented genotypic and/or phenotypic resistance to at least one ARV drug within three or more drug classes of antiretroviral medications and have difficulty in constructing a viable suppressive regimen.
- Have full viral sensitivity/susceptibility to at least one approved antiretroviral agent, other than UB-421, as determined by genotypic and/or phenotypic ARV drug resistance tests at screening, and such agent can be used as a component of OBT;
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- Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure;
- Have a life expectancy that is > 9 months;
- Laboratory values at Screening of:
- Absolute neutrophil count (ANC) ≥ 750/mm3;
- Hemoglobin (Hb) ≥ 10.5 gm/dL (male) or ≥ 9.5 gm/dL (female);
- Platelets ≥ 75,000 /mm3;
- Serum alanine transaminase (SGPT/ALT) < 2.5 x upper limit of normal (ULN);
- Serum aspartate transaminase (SGOT/AST) < 2.5 x ULN;
- Bilirubin (total) < 2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease; and
- Creatinine ≤ 1.5 x ULN
- Clinically normal resting 12-lead electrocardiogram (ECG) at the Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
- Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants,injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy test prior to receiving the first dose of study drug; and
- Willing and able to participate in all aspects of the study, including use of IV medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
Who cannot join
- Any currently active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: local cutaneous Kaposi's sarcoma, wasting syndrome due to HIV or any other AIDS-defining illness for which no therapeutic treatment is required OR the required treatment is not included in the list of prohibited medications;
- Subjects with baseline liver disease including active Hepatitis B or C infection or any other active infection secondary to HIV requiring acute therapy;
- Subjects with baseline CD4 counts < 350 cells/mm^3.
- Any ≥ Grade 3 laboratory abnormality according to the division of AIDS grading scale;
- Unexplained fever or clinically significant illness within 2 weeks prior to the first dose of study drug;
- Any vaccination within 2 weeks prior to the first dose of study drug;
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- Any immunomodulating therapy (excluding pre-medication steroid) or systemic chemotherapy within 4 weeks prior to the Screening Visit;
- Any radiation therapy within 4 weeks prior to the Screening Visit;
- Any previous exposure to monoclonal antibody for the treatment of HIV within 12 weeks prior to the Screening Visit (excluding ibalizumab);
- Participation in an experimental drug trial(s) within 4 weeks prior to the Screening Visit;
- Any prior exposure to UB-421;
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study; and
- Any significant diseases (other than HIV-1 infection) or clinically significant findings that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination With Optimized Background Therapy (OBT) Regimen in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
This is a Phase 2, multi-center study, designed to evaluate the efficacy, safety, and tolerability of UB-421 in conjunction with a failing existing ART regimen for 1 week and optimized background therapy (OBT) for 24 weeks, respectively.
- Conditions
- HIV-1 Infection
- Being tested
- UB-421, Optimized background therapy (OBT)
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
Optimized background therapy (OBT)Drug
The prescribed OBT must contain at least one agent to which the participant's virus is known to be fully sensitive.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Drug Resistant | Experimental | Not described Receives: Biological: UB-421; Drug: Optimized background therapy (OBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness by Viral Load Log10 Change from Baseline
Measured: 2 weeks
Secondary outcomes (3)
Number of participants with treatment-related adverse events
Measured: 35 weeks
Peak concentration of UB-421
Measured: 35 weeks
Trough concentration of UB-421
Measured: 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03164447
- Sponsor's protocol ID
- UBP-A205-HIV
- Status last verified
- May 2022
- First submitted
- 21 May 2017
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- 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 Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination With Optimized Background Therapy (OBT) Regimen in Patients With Multi-Drug Resistant (MDR) HIV-1 Infection
- ClinicalTrials.gov ID
- NCT03164447
- Acronym / sponsor ID
- UBP-A205-HIV
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 23 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.
This is a Phase 2, multi-center study, designed to evaluate the efficacy, safety, and tolerability of UB-421 in conjunction with a failing existing ART regimen for 1 week and optimized background therapy (OBT) for 24 weeks, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Drug Resistant | Experimental | Biological: UB-421, Drug: Optimized background therapy (OBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males and females, age ≥18 years;
- HIV-1 seropositive, with documented HIV-1 infection by official, signed, written history (eg. Laboratory report);
- Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening and are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
- Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA >200 copies/ml) within the last 3 months prior to the Screening Visit;
- Highly treatment-experienced HIV-infected patients with documented genotypic and/or phenotypic resistance to at least one ARV drug within three or more drug classes of antiretroviral medications and have difficulty in constructing a viable suppressive regimen.
Key exclusion criteria (13 listed)
- Any currently active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: local cutaneous Kaposi's sarcoma, wasting syndrome due to HIV or any other AIDS-defining illness for which no therapeutic treatment is required OR the required treatment is not included in the list of prohibited medications;
- Subjects with baseline liver disease including active Hepatitis B or C infection or any other active infection secondary to HIV requiring acute therapy;
- Subjects with baseline CD4 counts < 350 cells/mm^3.
- Any ≥ Grade 3 laboratory abnormality according to the division of AIDS grading scale;
- Unexplained fever or clinically significant illness within 2 weeks prior to the first dose of study 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-421Monoclonal antibody by IV infusion | Biological | Multi-Drug Resistant |
| Optimized background therapy (OBT)The prescribed OBT must contain at least one agent to which the participant's virus is known to be fully sensitive. | Drug | Multi-Drug Resistant |
Primary outcome
Effectiveness by Viral Load Log10 Change from Baseline
Time frame: 2 weeks
3 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 35 weeks
Peak concentration of UB-421
Time frame: 35 weeks
Trough concentration of UB-421
Time frame: 35 weeks
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 2 study testing UB-421 and Optimized background therapy (OBT) 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 19 inclusion and 13 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 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?
Contact Zhonghao Shi (+886-3-668-4800 ext. 3641, Zhonghao.Shi@unitedbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness by Viral Load Log10 Change from Baseline (time frame: 2 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 24 Apr 2023.