To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults
- Conditions
- HIV-1 Infection
- Interventions
- Drug: current standard HAART treatment
- Registration Number
- NCT03149211
- Lead Sponsor
- United BioPharma
- Brief Summary
The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption.
- Detailed Description
This is an open-label, Phase III study to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound while replace HAART in virally suppressed HIV-1 infected adults. In this study, approximately 375 subjects on stable HAART treatment will be randomized to receive either continuing HAART treatment alone (Cohort 1) or UB-421 as the monotherapy (Cohort 2) in 1:2 ratio. For Cohort 1, subjects will receive current standard HAART treatment as the active control group. For Cohort 2, UB-421 will be administered to enrolled subjects without HAART treatment in the Cohort 2 during the 26-week treatment period. After treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- HIV-1 sero-positive
- Aged 20 years or older
- Were not breastfeeding for women
- Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
- Subjects agree on using birth control barrier (female or male condom) during the entire study period
- Subjects sign the informed consent before undergoing any study procedures
- Any active infection except for HIV, and required immediate therapy
- Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
- Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
- Life expectancy less than 12 months
- Any alcohol or illicit drug used, according to the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 current standard HAART treatment Subjects will receive current standard HAART treatment as the active control group. Cohort 2 current standard HAART treatment Subjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment. Cohort 2 UB-421 Subjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment.
- Primary Outcome Measures
Name Time Method Number of participants without virologic failure 24 weeks
- Secondary Outcome Measures
Name Time Method Time to virologic failure 26 weeks Number of participants with treatment-related adverse events 48 weeks Peak concentration of UB-421 in Cohort 2 30 weeks Trough concentration of UB-421 in Cohort 2 30 weeks
Trial Locations
- Locations (1)
Beijing Youan Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Youan Hospital,Capital Medical University🇨🇳Beijing, Beijing, China