To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults

A Phase 2 study testing UB-421 in people with HIV-1 Infection, run by United BioPharma at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteTaiwan
Study dates: Jun 2015to Jul 2016
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
Aged 20 years or older
Have received HAART treatment
CD4+ T cell count ≧ 350 cells/mm3
HIV-1 plasma RNA level remains below the limit of
Were not breastfeeding for women

Show all 9Show fewer

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 documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before screening visit
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
Any vaccination within 8 weeks prior to the first dose of study drug
Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug

Show all 9Show fewer

Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug
Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
More than one change of HAART regimen because of virologic failure

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Veterans General Hospital
Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Phase II, Open-label, Multiple-dose Trial to Investigate the Safety and Efficacy of UB-421 Monotherapy in Substitution for Stable Antiretroviral Therapy in HIV Infected Adults

Read the detailed description

This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 29 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.

Conditions: HIV-1 Infection
Being tested: UB-421

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
The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).

Study groups in NCT02369146
Study group	Role	What they receive
cohort 1	Experimental	Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly Receives: Drug: UB-421
cohort 2	Experimental	Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly Receives: Drug: UB-421

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events
Measured: 17 weeks for cohort 1, 25 weeks for cohort 2

Secondary outcomes (2)

Peak concentration of UB-421
Measured: 8 weeks for cohort 1, 15 weeks for cohort 2
Trough concentration of UB-421
Measured: 8 weeks for cohort 1, 15 weeks for cohort 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Jul 2016

First posted23 Feb 2015 (estimated)
Study startJun 2015
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02369146
Sponsor's protocol ID: UBP-A202-HIV
Status last verified: Oct 2017
First submitted: 5 Feb 2015
Last updated: 31 Oct 2017
Results posted: No
Data monitoring committee: Yes

Publications

Wang CY, Wong WW, Tsai HC, Chen YH, Kuo BS, Lynn S, Blazkova J, Clarridge KE, Su HW, Lin CY, Tseng FC, Lai A, Yang FH, Lin CH, Tseng W, Lin HY, Finstad CL, Wong-Staal F, Hanson CV, Chun TW, Liao MJ. Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption. N Engl J Med. 2019 Apr 18;380(16):1535-1545. doi: 10.1056/NEJMoa1802264.
PubMed 30995373

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Open-label, Multiple-dose Trial to Investigate the Safety and Efficacy of UB-421 Monotherapy in Substitution for Stable Antiretroviral Therapy in HIV Infected Adults
ClinicalTrials.gov ID: NCT02369146
Acronym / sponsor ID: UBP-A202-HIV
Conditions: HIV-1 Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: United BioPharmaIndustry (pharma, biotech, devices)
Collaborators: Taipei Veterans General Hospital, Taiwan, Kaohsiung Veterans General Hospital., Kaohsiung Medical University Chung-Ho Memorial Hospital
Study start: Jun 2015
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 23 Feb 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
cohort 1	Experimental	Drug: UB-421Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly
cohort 2	Experimental	Drug: UB-421Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

HIV-1 sero-positive
Aged 20 years or older
Have received HAART treatment
CD4+ T cell count ≧ 350 cells/mm3
HIV-1 plasma RNA level remains below the limit of

Key exclusion criteria (9 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 documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before screening visit
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
Any vaccination within 8 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-421Also: dB4C7 mAbThe UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).	Drug	cohort 1, cohort 2

Primary outcome

Number of participants with adverse events
Time frame: 17 weeks for cohort 1, 25 weeks for cohort 2

2 secondary outcomes

Peak concentration of UB-421
Time frame: 8 weeks for cohort 1, 15 weeks for cohort 2
Trough concentration of UB-421
Time frame: 8 weeks for cohort 1, 15 weeks for cohort 2

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 31 Oct 2017.
Derived from this study: PubMed 30995373Wang CY, Wong WW, Tsai HC, Chen YH, Kuo BS, Lynn S, Blazkova J, Clarridge KE, Su HW, Lin CY, Tseng FC, Lai A, Yang FH, Lin CH, Tseng W, Lin HY, Finstad CL, Wong-Staal F, Hanson CV, Chun TW, Liao MJ. Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption. N Engl J Med. 2019 Apr 18;380(16):1535-1545. doi: 10.1056/NEJMoa1802264.

Related trials for HIV-1 Infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

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.

Wing Wai Wong, M.D. principal investigator

Taiwan, Taipei Veterans General Hospital

Yen Hsu Chen, M.D. PhD. principal investigator

Kaohsiung Medical University Chung-Ho Memorial Hospital

Hung Chin Tsai, M.D. PhD. principal investigator

Taiwan, Kaohsiung Veterans General Hospital

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 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 9 inclusion and 9 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 31 Oct 2017. 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?

Number of participants with adverse events (time frame: 17 weeks for cohort 1, 25 weeks for cohort 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02369146, which also lists 1 linked publication.

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 31 Oct 2017.