Study Stopped
The study will not be submitted to authority for IND application.
the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2020
Shorter than P25 for phase_2
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
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFebruary 21, 2020
November 1, 2019
8 months
July 31, 2019
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
treatment related TEAEs
the incidence of Grade 3 drug-related treatment-emergent adverse events
16 Weeks
Study Arms (2)
Arm1 (Standard ART)
ACTIVE COMPARATORStandard ART
Arm 2 (ART plus UB-421)
EXPERIMENTALART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 seropositive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- have been receiving antiretroviral therapy (ART) for more than 2 years
You may not qualify if:
- Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.
- History of anaphylaxis to monoclonal antibodies.
- Any vaccination within 8 weeks prior to the first dose of UB-421.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United BioPharmalead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2019
First Posted
August 1, 2019
Study Start
April 1, 2020
Primary Completion
December 1, 2020
Study Completion
March 1, 2021
Last Updated
February 21, 2020
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share