The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
1 other identifier
interventional
31
1 country
3
Brief Summary
This study evaluate the safety of UB-421 in combination with standard antiretroviral therapy (ART) and the efficacy of HIV reservoir reduction as compared with ART alone in ART stabilized HIV-1 patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2018
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedStudy Start
First participant enrolled
December 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 13, 2022
May 1, 2022
1.8 years
November 12, 2018
May 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
treatment related TEAEs
the incidence of Grade 3 drug-related treatment-emergent adverse events
48Weeks
Secondary Outcomes (1)
the change of immune profiles
16Weeks
Study Arms (3)
Standard ART
NO INTERVENTIONSubjects will receive standard ART for 48 weeks
UB-421(25mg/kg) Q2W add-on treatment
EXPERIMENTALUB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
UB-421(25mg/kg) Q4W add-on treatment
EXPERIMENTALUB-421(25 mg/kg) Q4W plus standard ART for 48 weeks
Interventions
Monoclonal antibody by IV infusion plus standard ART
Monoclonal antibody by IV infusion plus standard ART
Eligibility Criteria
You may qualify if:
- HIV-1 sero-positive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- HIV-1 plasma RNA level below 50 RNA copies/mL .
You may not qualify if:
- Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
- Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
- Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
- History of anaphylaxis to other mAbs.
- Any vaccination within 8 weeks prior to the first dose of assigned drug.
- Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United BioPharmalead
- National Taiwan University Hospitalcollaborator
- Taipei Veterans General Hospital, Taiwancollaborator
- Taoyuan General Hospitalcollaborator
- Kaohsiung Medical University Chung-Ho Memorial Hospitalcollaborator
- Kaohsiung Veterans General Hospital.collaborator
Study Sites (3)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Taipei Veterans General Hospital
Taipei, 201, Taiwan
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2018
First Posted
November 16, 2018
Study Start
December 12, 2018
Primary Completion
October 15, 2020
Study Completion
December 31, 2021
Last Updated
May 13, 2022
Record last verified: 2022-05