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NCT Number: NCT05056974

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

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.

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Key information

Conditions

HIV-1 Infection

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 20 years or older.
  • No breastfeeding or pregnancy for women.
  • Have been receiving ART for more than 3 years by screening visit 1 (SV1).
  • Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
  • Subjects must sign the informed consent before undergoing any study procedures.

Exclusion criteria

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

Treatment and study plan

UB-421

Biological

10 mg/kg, weekly UB-421 during the 8-week

Chidamide

Drug

10 mg/dose, twice a week for 8 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

United BioPharma

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2021
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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