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

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression.

Detailed Description
-----------------
This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 29 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.

Official Title
-----------------
A Phase II, Open-label, Multiple-dose Trial to Investigate the Safety and Efficacy of UB-421 Monotherapy in Substitution for Stable Antiretroviral Therapy in HIV Infected Adults

Conditions
-----------------
HIV-1 Infection

Intervention / Treatment
-----------------
* Drug: UB-421


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 sero-positive Aged 20 years or older Have received HAART treatment CD4+ T cell count ≧ 350 cells/mm3 HIV-1 plasma RNA level remains below the limit of 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 documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before screening visit 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 Any vaccination within 8 weeks prior to the first dose of study drug Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations More than one change of HAART regimen because of virologic failure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cohort 1<br>Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly | Drug: UB-421<br>* The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).<br>* Other names: dB4C7 mAb;|
| Experimental: cohort 2<br>Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly | Drug: UB-421<br>* The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).<br>* Other names: dB4C7 mAb;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 17 weeks for cohort 1, 25 weeks for cohort 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak concentration of UB-421 |  | 8 weeks for cohort 1, 15 weeks for cohort 2 | 
| Trough concentration of UB-421 |  | 8 weeks for cohort 1, 15 weeks for cohort 2 |