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

May 12, 2022 updated by: United BioPharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital
      • Taipei, Taiwan, 201
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  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. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
  3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
  4. History of anaphylaxis to other mAbs.
  5. Any vaccination within 8 weeks prior to the first dose of assigned drug.
  6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
  7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard ART
Subjects will receive standard ART for 48 weeks
Experimental: UB-421(25mg/kg) Q2W add-on treatment
UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
Biological: UB-421(25 mg/kg) Q2W
Monoclonal antibody by IV infusion plus standard ART
Experimental: UB-421(25mg/kg) Q4W add-on treatment
UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks
Biological: UB-421(25 mg/kg) Q4W
Monoclonal antibody by IV infusion plus standard ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment related TEAEs
Time Frame: 48Weeks
the incidence of Grade 3 drug-related treatment-emergent adverse events
48Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of immune profiles
Time Frame: 16Weeks
Change in Treg percentage in the peripheral blood
16Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United BioPharma

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBP-A209-HIV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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