Trial | NCT02369146  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ub-421 ...

  • Study Participants

    29
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.
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.
Study Started
Jun 30
2015
Primary Completion
Jul 31
2016
Study Completion
Jul 31
2016
Last Update
Oct 31
2017

Drug UB-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).

  • Other names: dB4C7 mAb

cohort 1 Experimental

Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly

cohort 2 Experimental

Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly

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
No Results Posted