- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04406727
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
April 21, 2023 updated by: United BioPharma
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Linda Shih
- Phone Number: 3204 +886-3-668-4800
- Email: linda.shih@unitedbiopharma.com
Study Contact Backup
- Name: Zhonghao Shi
- Phone Number: 3201 +886-3-668-4800
- Email: zhonghao.shi@unitedbiopharma.com
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- HIV-1 seropositive
- Have a history of at least 6 months on antiretroviral treatment
- Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening
Exclusion Criteria:
- Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)
- Females who are pregnant
- Any vaccination within 2 weeks prior to the Screening
- Any prior exposure to UB-421
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: Quadruple
Arms and Interventions
Participant Group / 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). |
UB-421 in combination with their 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). |
Antiretroviral (ARV)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HIV-1 RNA viral load between 2 arms
Time Frame: 14 Days
|
14 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
December 1, 2023
Primary Completion (Anticipated)
June 30, 2026
Study Completion (Anticipated)
June 30, 2026
Study Registration Dates
First Submitted
May 22, 2020
First Submitted That Met QC Criteria
May 22, 2020
First Posted (Actual)
May 28, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 21, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- HIV Infections
- Infections
- Communicable Diseases
- Anti-Infective Agents
- Antiviral Agents
- Anti-Retroviral Agents
- UB-421
Other Study ID Numbers
- UBP-A308-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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