Title
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
Phase
Phase 2Lead Sponsor
UBP Greater China (Shanghai) Co., LtdStudy Type
InterventionalStatus
Not yet recruitingIndication/Condition
HIV-1-infectionIntervention/Treatment
UB-421(25 mg/kg) Q2W UB-421(25 mg/kg) Q4WStudy Participants
39This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.
Monoclonal antibody by IV infusion plus standard ART
Monoclonal antibody by IV infusion plus standard ART
Subjects will receive standard ART for 48 weeks
UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks
Inclusion Criteria: HIV-1 sero-positive Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg. HIV-1 plasma RNA level below 50 RNA copies/mL. Exclusion Criteria: Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive. History of anaphylaxis to other mAbs. Any vaccination within 8 weeks prior to the first dose of assigned drug. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
