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NCT04406727 Clinical Trial

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

HIV-1 Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04406727
Other study ID # UBP-A308-HIV
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date December 1, 2023
Est. completion date June 30, 2026

Study information
Verified date April 2023
Source United BioPharma
Contact Linda Shih
Phone +886-3-668-4800
Email linda.shih@unitedbiopharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• UB-421
UB-421 in combination with their ARV
Other:
• Antiretroviral (ARV)
Antiretroviral (ARV)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
United BioPharma

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HIV-1 RNA viral load between 2 arms 14 Days
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