The HIV Functional Cure Potential of UB-421 in ART Stabil... | NCT04404049

Studies
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

NCT04404049

Sponsor

UBP Greater China (Shanghai) Co., Ltd

Status

Unknown status

Last Update Posted

May 18, 2022Actual

Enrollment

39Estimated

Phase

Phase 2

Conditions

HIV-1-infection

Interventions

UB-421(25 mg/kg) Q2W
UB-421(25 mg/kg) Q4W

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

Official Title

The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to 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

Status Module

Record Verification Date

May 2022

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, 2024Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

May 21, 2020

First Submission Date that Met QC Criteria

May 21, 2020

First Posted Date

May 27, 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

May 16, 2022

Last Update Posted Date

May 18, 2022Actual

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

This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard ART	No Intervention	Subjects will receive standard ART for 48 weeks
UB-421(25mg/kg) Q2W add-on treatment	Experimental	UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks	Biological: UB-421(25 mg/kg) Q2W
UB-421(25mg/kg) Q4W add-on treatment	Experimental	UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks	Biological: UB-421(25 mg/kg) Q4W

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UB-421(25 mg/kg) Q2W	Biological	Monoclonal antibody by IV infusion plus standard ART	UB-421(25mg/kg) Q2W add-on treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment related TEAEs	the incidence of Grade 3 drug-related treatment-emergent adverse events	48Weeks

Secondary Outcomes

Measure	Description	Time Frame
the change of immune profiles	Change in Treg percentage in the peripheral blood	16Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000630912	UB-421

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided