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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

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ClinicalTrials.gov Identifier: NCT04041362
Recruitment Status : Withdrawn (The study will not be submitted to authority for IND application.)
First Posted : August 1, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
United BioPharma

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
HIV-1 Infection Biological: UB-421 Other: Antiretroviral Therapy (ART) Phase 2

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. treatment related TEAEs [ Time Frame: 16 Weeks ]
    the incidence of Grade 3 drug-related treatment-emergent adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT04041362    
Other Study ID Numbers: UBP-A213-HIV
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents