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the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

Sponsor
United BioPharma (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04041362
Collaborator
(none)
0
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.

Condition or Disease Intervention/Treatment Phase
  • Biological: UB-421
  • Other: Antiretroviral Therapy (ART)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm1 (Standard ART)

Standard ART

Other: Antiretroviral Therapy (ART)
Standard ART
Experimental: Arm 2 (ART plus UB-421)

ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks

Biological: UB-421
Monoclonal antibody by IV infusion plus standard ART

Other: Antiretroviral Therapy (ART)
Standard ART

Outcome Measures

Primary Outcome Measures

  1. treatment related TEAEs [16 Weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. HIV-1 seropositive

  2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.

  3. have been receiving antiretroviral therapy (ART) for more than 2 years

Exclusion Criteria:

  1. Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.

  2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.

  3. History of anaphylaxis to monoclonal antibodies.

  4. Any vaccination within 8 weeks prior to the first dose of UB-421.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • United BioPharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
United BioPharma
ClinicalTrials.gov Identifier:
NCT04041362
Other Study ID Numbers:
  • UBP-A213-HIV
First Posted:
Aug 1, 2019
Last Update Posted:
Feb 21, 2020
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by United BioPharma
HIV
UB-421
Additional relevant MeSH terms:
Anti-Retroviral Agents
UB-421

Study Results

No Results Posted as of Feb 21, 2020