Status:
NOT_YET_RECRUITING
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
Lead Sponsor:
United BioPharma
Conditions:
HIV-1 Infection
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04406727
Start Date
December 1 2023
End Date
June 30 2026
Last Update
April 24 2023
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