UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2023
Typical duration for phase_3
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
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 24, 2023
April 1, 2023
2.6 years
May 22, 2020
April 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HIV-1 RNA viral load between 2 arms
14 Days
Study Arms (2)
UB-421
EXPERIMENTAL2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).
Placebo
ACTIVE COMPARATOR2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 seropositive
- Have a history of at least 6 months on antiretroviral treatment
- Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening
You may not qualify if:
- Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST \> 4 x upper limit of normal (ULN)
- Females who are pregnant
- Any vaccination within 2 weeks prior to the Screening
- Any prior exposure to UB-421
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United BioPharmalead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 28, 2020
Study Start
December 1, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 24, 2023
Record last verified: 2023-04