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

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.

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