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
NCT ID: NCT04041362
Last Updated: 2020-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2020-04-30
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm1 (Standard ART)
Standard ART
Antiretroviral Therapy (ART)
Standard ART
Arm 2 (ART plus UB-421)
ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks
UB-421
Monoclonal antibody by IV infusion plus standard ART
Antiretroviral Therapy (ART)
Standard ART
Interventions
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UB-421
Monoclonal antibody by IV infusion plus standard ART
Antiretroviral Therapy (ART)
Standard ART
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
100 Years
ALL
No
Sponsors
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United BioPharma
INDUSTRY
Responsible Party
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Other Identifiers
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UBP-A213-HIV
Identifier Type: -
Identifier Source: org_study_id
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