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

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: NCT05056974
Recruitment Status : Recruiting
First Posted : September 27, 2021
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
United BioPharma

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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Biological: UB-421 Drug: chidamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs Among ART Stabilized HIV-1 Patients Who Undergo ART Interruption
Actual Study Start Date : December 2, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: UB-421 + chidamide
UB-421 + chidamide combination therapy
Biological: UB-421
10 mg/kg, weekly UB-421 during the 8-week

Drug: chidamide
10 mg/dose, twice a week for 8 weeks




Primary Outcome Measures :
  1. HIV cell-associated RNA levels [ Time Frame: Post-treatment weeks up to 48 weeks ]
    The change in HIV-1 Total DNA from baseline after study drug administration.


Secondary Outcome Measures :
  1. HIV-1 Total DNA levels [ Time Frame: Post-treatment weeks up to 48 weeks ]
    The changes in HIV-1 Total DNA levels during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects with active systemic infections, except for HIV-1
  2. Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
  3. Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
  4. Any alcohol or illicit drug use
  5. Receipt of any other investigational study agent(s) within 90 days before SV2.
  6. Currently on the treatment for 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): NCT05056974


Contacts
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Contact: Zhonghao Shi +886-3-668-4800 ext 3201 zhonghao.shi@unitedbiopharma.com

Locations
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Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung City, Taiwan, Taiwan
Contact: PEI-HUA HSIEH         
Sponsors and Collaborators
United BioPharma
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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT05056974    
Other Study ID Numbers: UBP-A232-HIV
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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UB-421
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents