To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase III, Randomized, Open-label, Controlled Trial to Investigate the Efficacy and Safety of UB-421 Monotherapy as Substitution for Stable Antiretroviral Therapy in HIV-1 Infected Adults

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Drug: UB-421
* Drug: current standard HAART treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1<br>Subjects will receive current standard HAART treatment as the active control group. | Drug: current standard HAART treatment<br>* Subjects will receive current standard HAART treatment as the active control group.<br>|
| Experimental: Cohort 2<br>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. | Drug: UB-421<br>* Subjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks).<br>* Other names: dB4C7 mAb;Drug: current standard HAART treatment<br>* Subjects will receive current standard HAART treatment as the active control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants without virologic failure |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |