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 |
| 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 |