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

NCT04985890 | Not Yet Recruiting Phase 2

• 1 other identifier: UBP-A230-HIV
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV-1-infection

Keywords

UB-421; HIV

Outcome Measures

Primary Outcomes (1)

• HIV-1 Total DNA levels

  The change in HIV-1 Total DNA from baseline after the study drug administration.

  Post-treatment weeks up to 48 weeks

Secondary Outcomes (4)

• HIV-1 Total DNA levels

  Post-treatment weeks up to 48 weeks

• Treatment related TEAE

  through study completion, an average of 0.5 year

• Viral suppression

  Post-treatment weeks up to 48 weeks

• The number of adverse subjects

  Post-treatment weeks up to 48 weeks

Study Arms (2)

UB-421 monotherapy

EXPERIMENTAL

Subjects will receive 10 mg/kg UB-421 weekly infusion for 8 weeks.

Biological: UB-421

UB-421 + chidamide combination therapy

EXPERIMENTAL

Subjects will receive 10 mg/kg UB-421 weekly infusion and 10 mg chidamide twice a week administration for 8weeks.

Other: UB-421+chidamide

Interventions

UB-421 BIOLOGICAL

10mg/kg weekly intravenous infusion to substitute for for antiretroviral therapy

UB-421 monotherapy

UB-421+chidamide OTHER

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.

UB-421 + chidamide combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• UBP Greater China (Shanghai) Co., Ltd: lead

MeSH Terms

Interventions

UB-421

Study Officials

• undergoing undergoing, MD

  undergoing

  STUDY CHAIR

Central Study Contacts

Linda Shih, MSc

CONTACT

+886 36684800; linda.shih@unitedbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 2, 2021
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 10, 2023

Record last verified: 2022-08