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Completed

NCT Number: NCT03743376

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

This study evaluate the safety of UB-421 in combination with standard antiretroviral therapy (ART) and the efficacy of HIV reservoir reduction as compared with ART alone in ART stabilized HIV-1 patients

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Key information

Conditions

HIV-1 Infection

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV-1 sero-positive
  • Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
  • HIV-1 plasma RNA level below 50 RNA copies/mL .

Exclusion criteria

  • Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
  • Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
  • Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
  • History of anaphylaxis to other mAbs.
  • Any vaccination within 8 weeks prior to the first dose of assigned drug.
  • Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
  • Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.

Treatment and study plan

UB-421(25 mg/kg) Q2W

Biological

Monoclonal antibody by IV infusion plus standard ART

UB-421(25 mg/kg) Q4W

Biological

Monoclonal antibody by IV infusion plus standard ART

Primary outcomes

  1. treatment related TEAEs

    Time frame: 48Weeks

    the incidence of Grade 3 drug-related treatment-emergent adverse events

Secondary outcomes

  1. the change of immune profiles

    Time frame: 16Weeks

    Change in Treg percentage in the peripheral blood

Sponsors and collaborators

Lead sponsor

United BioPharma

Industry

Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Veterans General Hospital.
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital, Taiwan
  • Taoyuan General Hospital

Registry information

Official study title

The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 16, 2018
Registry last updated
May 13, 2022

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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