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A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir

Studies

Study First Submitted Date 2021-07-08
Study First Posted Date 2021-08-02
Last Update Posted Date 2023-05-10
Start Month Year March 2024
Primary Completion Month Year December 2026
Verification Month Year August 2022
Verification Date 2022-08-31
Last Update Posted Date 2023-05-10

Browse Interventions

Sequence: 96551064 Sequence: 96551065 Sequence: 96551066 Sequence: 96551067
Mesh Term UB-421 Mesh Term Anti-Retroviral Agents Mesh Term Antiviral Agents Mesh Term Anti-Infective Agents
Downcase Mesh Term ub-421 Downcase Mesh Term anti-retroviral agents Downcase Mesh Term antiviral agents Downcase Mesh Term anti-infective agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52479490
Name HIV-1-infection
Downcase Name hiv-1-infection

Id Information

Sequence: 40379339
Id Source org_study_id
Id Value UBP-A230-HIV

Design Groups

Sequence: 55935562 Sequence: 55935563
Group Type Experimental Group Type Experimental
Title UB-421 monotherapy Title UB-421 + chidamide combination therapy
Description Subjects will receive 10 mg/kg UB-421 weekly infusion for 8 weeks. Description Subjects will receive 10 mg/kg UB-421 weekly infusion and 10 mg chidamide twice a week administration for 8weeks.

Interventions

Sequence: 52789259 Sequence: 52789260
Intervention Type Biological Intervention Type Other
Name UB-421 Name UB-421+chidamide
Description 10mg/kg weekly intravenous infusion to substitute for for antiretroviral therapy Description 10 mg/kg UB-421 weekly intravenous infusion to substitute for antiretroviral therapy, and combined with oral 10 mg chidamide twice a week for 8 weeks. Chidamide taken on the one day and three days after the administration of UB-421.

Keywords

Sequence: 80287322 Sequence: 80287323
Name UB-421 Name HIV
Downcase Name ub-421 Downcase Name hiv

Design Outcomes

Sequence: 178535712 Sequence: 178535713 Sequence: 178535714 Sequence: 178535715 Sequence: 178535716
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure HIV-1 Total DNA levels Measure HIV-1 Total DNA levels Measure Treatment related TEAE Measure Viral suppression Measure The number of adverse subjects
Time Frame Post-treatment weeks up to 48 weeks Time Frame Post-treatment weeks up to 48 weeks Time Frame through study completion, an average of 0.5 year Time Frame Post-treatment weeks up to 48 weeks Time Frame Post-treatment weeks up to 48 weeks
Description The change in HIV-1 Total DNA from baseline after the study drug administration. Description The changes in HIV-1 Total DNA levels during the study Description The incidence of Grade 3 or higher grade drug-related treatment-emergent adverse events (TEAE) Description Descriptive analysis of loss of viral suppression (HIV-1 VL> 50 copies/ml) during the study period. Description The number of adverse subjects leading to discontinuation of UB 421 or Chidamide.

Sponsors

Sequence: 48605773
Agency Class INDUSTRY
Lead Or Collaborator lead
Name UBP Greater China (Shanghai) Co., Ltd

Overall Officials

Sequence: 29446976
Role Study Chair
Name undergoing undergoing, MD
Affiliation undergoing

Central Contacts

Sequence: 12088003
Contact Type primary
Name Linda Shih, MSc
Phone +886 36684800
Email linda.shih@unitedbiopharma.com
Phone Extension 3851
Role Contact

Design Group Interventions

Sequence: 68571412 Sequence: 68571413
Design Group Id 55935562 Design Group Id 55935563
Intervention Id 52789259 Intervention Id 52789260

Eligibilities

Sequence: 30942222
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: Subjects are eligible to be included in the study only if ALL of the following criteria apply: 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 18 years or older. Have been receiving at least (≧) 2 nucleoside/ nucleotide reverse transcriptase inhibitors (NRTI) plus one non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI, either boosted or un-boosted), integrase strand transfer inhibitor (INSTI) or entry inhibitor (EI) for more than 1 years. Have more than 2 different alternative options of optimized ART regimen. HIV-1 plasma viral load (VL) level well suppressed below 50 RNA copies/mL for at least (≧) 12 months. No breastfeeding or pregnancy for women. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (eg, barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectable, combinational oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test. Subjects must sign the informed consent before undergoing any study procedures. Exclusion Criteria: Subjects meeting ANY of the following criteria will be excluded from the study: Subjects with active systemic infections, except for HIV-1, that the investigator feels the infections may confound evaluation and treatment for HIV-1. Any acquired AIDS-defining illness such as non-Hodgkin's lymphoma or Kaposi's sarcoma according to the U.S. Centers for Disease Control and Prevention Classification System for HIV-1 Infection within the past 12 months . Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks . Any exposure to a monoclonal antibody within the past 12 weeks. Any significant diseases (other than HIV-1 infection) or clinically significant findings, that, in the Investigator's opinion, would preclude the subject from well participation or confound the assessment of study objectives. Current receiving treatment regimen for Diabetes, hepatitis B, hepatitis C, or latent tuberculosis. History of anaphylaxis to any monoclonal antibodies or HDAC inhibitor agents. Received blood transfusion or hematopoietic growth factor treatment, any vaccine, or a compound with HDAC inhibitor activity (such as valproic acid) recently. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to V1. More than one change of ART regimen because of the inability to achieve or maintain suppression of viral replication to an HIV-1 RNA level < 200 copies/mL within the past 12 months Receipt of any other investigational study agent(s) within 90 days. Experienced urticaria in recent 6 months or ongoing or unresolved skin problems with rash-like symptoms .
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254282743
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4

Designs

Sequence: 30687832
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29054569
Responsible Party Type Sponsor