A Proof-of-concept Trial to Evaluate the Safety and Effic... | NCT05056974

Studies
A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs

NCT05056974

Sponsor

United BioPharma

Status

Completed

Last Update Posted

Feb 15, 2023Actual

Enrollment

11Actual

Phase

Phase 2

Conditions

HIV-1 Infection

Interventions

UB-421
chidamide

Countries

Taiwan

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2021Actual

Primary Completion Date

Feb 1, 2023Actual

Completion Date

Feb 1, 2023Actual

First Submitted Date

Aug 18, 2021

First Submission Date that Met QC Criteria

Sep 22, 2021

First Posted Date

Sep 27, 2021Actual

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

Feb 13, 2023

Last Update Posted Date

Feb 15, 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

This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UB-421 + chidamide	Experimental	UB-421 + chidamide combination therapy	Biological: UB-421 Drug: chidamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UB-421	Biological	10 mg/kg, weekly UB-421 during the 8-week	UB-421 + chidamide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HIV cell-associated RNA levels	The change in HIV-1 Total DNA from baseline after study drug administration.	Post-treatment weeks up to 48 weeks

Secondary Outcomes

Measure	Description	Time Frame
HIV-1 Total DNA levels	The changes in HIV-1 Total DNA levels during the study	Post-treatment weeks up to 48 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history
Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
No breastfeeding or pregnancy for women.
Have been receiving ART for more than 3 years by screening visit 1 (SV1).
Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
Subjects must sign the informed consent before undergoing any study procedures.

Exclusion Criteria:

Subjects with active systemic infections, except for HIV-1
Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
Any alcohol or illicit drug use
Receipt of any other investigational study agent(s) within 90 days before SV2.
Currently on the treatment for diabetes.

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

Intervention Browse Module

MeSH Terms

ID	Term
C000630912	UB-421
C547816	N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided