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UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406727
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
United BioPharma

Brief Summary:
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Biological: UB-421 Other: Antiretroviral (ARV) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: UB-421

2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV

Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

Biological: UB-421
UB-421 in combination with their ARV

Other: Antiretroviral (ARV)
Antiretroviral (ARV)

Active Comparator: Placebo

2-arm Comparison Phase: Placebo in combination with ARV

Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

Other: Antiretroviral (ARV)
Antiretroviral (ARV)




Primary Outcome Measures :
  1. Change in HIV-1 RNA viral load between 2 arms [ Time Frame: 14 Days ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. HIV-1 seropositive
  2. Have a history of at least 6 months on antiretroviral treatment
  3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening

Exclusion Criteria:

  1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)
  2. Females who are pregnant
  3. Any vaccination within 2 weeks prior to the Screening
  4. Any prior exposure to UB-421

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406727


Contacts
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Contact: Linda Shih +886-3-668-4800 ext 3204 linda.shih@unitedbiopharma.com
Contact: Zhonghao Shi +886-3-668-4800 ext 3201 zhonghao.shi@unitedbiopharma.com

Sponsors and Collaborators
United BioPharma
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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT04406727    
Other Study ID Numbers: UBP-A308-HIV
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
HIV Infections
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
UB-421
Antiviral Agents
Anti-Infective Agents