HIV-1 Infection
Conditions
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.
Interventions
DRUGUB-421
Subjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks).
DRUGcurrent standard HAART treatment
Subjects will receive current standard HAART treatment as the active control group.
Sponsors
United BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants without virologic failure | 24 weeks |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed