HIV-1 Infection
Conditions
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.
Interventions
DRUGUB-421
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).
Sponsors
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital
United BioPharma
Study design
Allocation
NON_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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 17 weeks for cohort 1, 25 weeks for cohort 2 |
Secondary
| Measure | 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 |
Countries
Taiwan
Outcome results
None listed