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
Overview
- Phase
- Phase 2
- Intervention
- UB-421
- Conditions
- HIV-1 Infection
- Sponsor
- United BioPharma
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
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
Arms & Interventions
cohort 1
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly
Intervention: UB-421
cohort 2
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly
Intervention: UB-421
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: 17 weeks for cohort 1, 25 weeks for cohort 2
Secondary Outcomes
- 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)