UB-421 in Combination With Optimized Background Regimen i... | NCT04406727

Studies
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

NCT04406727

Sponsor

United BioPharma

Status

Unknown status

Last Update Posted

Apr 24, 2023Actual

Enrollment

50Estimated

Phase

Phase 3

Conditions

HIV-1 Infection

Interventions

UB-421
Antiretroviral (ARV)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

May 22, 2020

First Submission Date that Met QC Criteria

May 22, 2020

First Posted Date

May 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2023

Last Update Posted Date

Apr 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UB-421	Experimental	2-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).	Biological: UB-421 Other: Antiretroviral (ARV)
Placebo	Active Comparator	2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).	Other: Antiretroviral (ARV)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UB-421	Biological	UB-421 in combination with their ARV	UB-421
Antiretroviral (ARV)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HIV-1 RNA viral load between 2 arms		14 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Linda Shih	Contact	+886-3-668-4800	3204	linda.shih@unitedbiopharma.com
Zhonghao Shi	Contact	+886-3-668-4800	3201	zhonghao.shi@unitedbiopharma.com

Overall Officials

Not provided

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000630912	UB-421
D044966	Anti-Retroviral Agents

Ancestor Terms

ID	Term
D000998	Antiviral Agents
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided