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
Phase 2
Withdrawn
- Conditions
- HIV-1 Infection
- Interventions
- Other: Antiretroviral Therapy (ART)Biological: UB-421
- Registration Number
- NCT04041362
- Lead Sponsor
- United BioPharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm1 (Standard ART) Antiretroviral Therapy (ART) Standard ART Arm 2 (ART plus UB-421) UB-421 ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks Arm 2 (ART plus UB-421) Antiretroviral Therapy (ART) ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks
- Primary Outcome Measures
Name Time Method treatment related TEAEs 16 Weeks the incidence of Grade 3 drug-related treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method