Status:
WITHDRAWN
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
Lead Sponsor:
United BioPharma
Conditions:
HIV-1 Infection
Eligibility:
All Genders
20-100 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- HIV-1 seropositive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- have been receiving antiretroviral therapy (ART) for more than 2 years
Exclusion
- Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
- 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.
- History of anaphylaxis to monoclonal antibodies.
- Any vaccination within 8 weeks prior to the first dose of UB-421.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04041362
Start Date
April 1 2020
End Date
March 1 2021
Last Update
February 21 2020
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