Clinical Trials

MainTitle

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

This study has been withdrawn
Sponsor
United BioPharma


Information provided by (Responsible Party)
United BioPharma
ClinicalTrials.gov Identifier
NCT04041362

First received: July 31, 2019
Last updated: February 18, 2020
Last Verified: November 2019
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV-1 Infection

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

Study Type: Interventional
Study Design: 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

Further study details as provided by United BioPharma:

Primary Outcome Measures

  • treatment related TEAEs [ Time Frame: 16 Weeks ]
    the incidence of Grade 3 drug-related treatment-emergent adverse events

Enrollment: 0
Study Start Date: April 2020
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 20 Years to 100 Years  
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.

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04041362

Sponsors and Collaborators

United BioPharma
More Information

More Information


Responsible Party: United BioPharma  
ClinicalTrials.gov Identifier: NCT04041362   History of Changes  
Other Study ID Numbers: UBP-A213-HIV  
Study First Received: July 31, 2019  
Last Updated: February 18, 2020  
Individual Participant Data    
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

ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.