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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04985890
Recruitment Status : Not yet recruiting
First Posted : August 2, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
UBP Greater China (Shanghai) Co., Ltd

Brief Summary:
  • To assess the impact of UB-421 and chidamide in changing HIV-1 viral reservoir profile among HIV-1 suppressed patients who undergo short-term ART interruption.
  • To evaluate the safety and tolerability of UB-421 combined with chidamide among HIV-1 suppressed patients who undergo short-term ART interruption.

Condition or disease Intervention/treatment Phase
HIV-1-infection Biological: UB-421 Other: UB-421+chidamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study to Evaluate the Safety and Efficacy of UB-421 in Combination With Chidamide for Reduction of HIV Reservoir as Compared to UB-421 Alone in ART Stabilized HIV-1 Patients Who Undergo ART Interruption
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: UB-421 monotherapy
Subjects will receive 10 mg/kg UB-421 weekly infusion for 8 weeks.
Biological: UB-421
UB-421 will be used 10mg/kg weekly intravenous infusion for 8 weeks. Antiretroviral therapy will be interrupted during entire study.

Experimental: UB-421 + chidamide combination therapy
Subjects will receive 10 mg/kg UB-421 weekly infusion and 10 mg chidamide twice a week administration for 8weeks.
Other: UB-421+chidamide
10 mg/kg UB-421 weekly intravenous infusion combined with oral 10 mg chidamide twice a week for 8 weeks. The dates of taking chidamide will be on the one day and three days after the first administration of UB-421.Antiretroviral therapy will be interrupted during entire study.




Primary Outcome Measures :
  1. HIV-1 Total DNA levels [ Time Frame: screening visit and week 9 ]
    The change in HIV-1 Total DNA from baseline at the ninth week after the first administration.


Secondary Outcome Measures :
  1. HIV-1 Total DNA levels [ Time Frame: screening visit, week 4,9 and 14 ]
    The changes in HIV-1 Total DNA levels during the study

  2. Treatment related TEAE [ Time Frame: through study completion, an average of 0.5 year ]
    The incidence of Grade 3 or higher grade drug-related treatment-emergent adverse events (TEAE)

  3. Viral suppression [ Time Frame: screening visit and week 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 14 ]
    Descriptive analysis of loss of viral suppression (HIV-1 VL> 50 copies/ml) during the study period.

  4. Tolerability of study treatment [ Time Frame: week 1 to week 8 ]
    The number of adverse events leading to discontinuation of UB 421 or Chidamide.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects are eligible to be included in the study only if ALL of the following criteria apply:

  1. HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history (e.g., a laboratory report).
  2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 18 years or older.
  3. Have been receiving ART, defined as 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 by screening visit 1 (SV1).
  4. Have more than 2 different alternative options of optimized ART regimen.
  5. HIV-1 plasma viral load (VL) level below 50 RNA copies/mL for at least (≧) 12 months prior to SV2, with at least 2 viral load measurements within 12 months.
  6. HIV-1 Plasma VL should also be below 50 RNA copies/mL at SV2.
  7. HIV total DNA ≥ 300 copies per million CD4+ T cells at SV1.
  8. With 2 records of CD4+ T cell count ≧ 350 cells/mm3 that were measured at least 12 weeks apart during the 12 months before SV2.
  9. With a CD4+ T cell count ≧ 350 cells/mm3 obtained at SV2.
  10. No breastfeeding or pregnancy for women.
  11. 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 at SV2.
  12. Laboratory values at SV2 should meet:

    1. Platelets ≥ 75 × 109/L
    2. Absolute neutrophil count ≥ 1.5×109/L
    3. Hemoglobin ≥ 10 g/dL
    4. Serum alanine transaminase (serum glutamic-pyruvic transaminase/alanine transaminase [GPT/ALT]) or serum aspartate transaminase (serum glutamic-oxaloacetic transaminase/aspartate transaminase [GOT/AST]) ≤ 2.5x upper limit of normal (ULN)
    5. Bilirubin (total) < 1.5 x ULN
    6. Serum creatinine ≤ 1.5 x ULN
  13. 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:

  1. Subjects with active systemic infections, except for HIV-1, that the investigator feels the infections may confound evaluation and treatment for HIV-1.
  2. 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 before SV2.
  3. Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before SV2.
  4. Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
  5. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from the screening, medical history, and/or physical examination that, in the Investigator's opinion, would preclude the subject from good compliance and well participation in this study.
  6. Current receiving treatment regimen for hepatitis B and hepatitis C or latent tuberculosis.
  7. History of anaphylaxis to any monoclonal antibodies or HDAC inhibitor agents.
  8. Received blood transfusion or hematopoietic growth factor treatment within 3 months before the screening visit (SV2), or received a compound with HDAC inhibitor activity (such as valproic acid) within 1 month before the SV1. Potential participants can be considered after the indicated wash-out periods of these drugs/agents.
  9. Any vaccination within 8 weeks prior to V1.
  10. Use of immunomodulators (including interleukins, interferon, cyclosporine, continual use of systemic corticosteroid for more than 30 days), HIV vaccine, or systemic chemotherapy within 180 days prior to V1.
  11. Any alcohol or illicit drug use, according to the Investigator's opinion, will interfere with subject's ability to comply with the dosing, visit schedules and protocol evaluations.
  12. 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 before SV2.
  13. Receipt of any other investigational study agent(s) within 90 days before SV2.
  14. A history of clinically significant cardiac diseases, including symptomatic or asymptomatic arrhythmias, syncopal episodes, or hyperactive/venous thrombosis events 6 months before SV1, such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis or pulmonary embolism.
  15. Experienced urticaria in the 6 months before the screening visit (SV2) or had ongoing or unresolved skin problems with rash-like symptoms (eg. eczema, atopic dermatitis, urticaria) at SV2.
  16. Diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985890


Contacts
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Contact: Linda Shih, MSc +886 36684800 ext 3851 linda.shih@unitedbiopharma.com

Sponsors and Collaborators
UBP Greater China (Shanghai) Co., Ltd
Investigators
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Study Chair: undergoing undergoing, MD undergoing
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Responsible Party: UBP Greater China (Shanghai) Co., Ltd
ClinicalTrials.gov Identifier: NCT04985890    
Other Study ID Numbers: UBP-A230-HIV
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UBP Greater China (Shanghai) Co., Ltd:
UB-421
HIV
Additional relevant MeSH terms:
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UB-421
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents