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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
United BioPharma

Collaborator
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Information provided by (Responsible Party)
United BioPharma
ClinicalTrials.gov Identifier
NCT02369146

First received: February 5, 2015
Last updated: August 2, 2016
Last Verified: May 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV-1 Infection

Drug : UB-421
Phase 2

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

Further study details as provided by United BioPharma:

Primary Outcome Measures

  • Number of participants with adverse events [ Time Frame: 17 weeks for cohort 1, 25 weeks for cohort 2 ]
Secondary Outcome Measures:
  • Peak concentration of UB-421 [ Time Frame: 8 weeks for cohort 1, 15 weeks for cohort 2 ]
  • Trough concentration of UB-421 [ Time Frame: 8 weeks for cohort 1, 15 weeks for cohort 2 ]

Enrollment: 28
Study Start Date: June 2015
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: cohort 1
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly
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 Name: dB4C7 mAb
Experimental: cohort 2
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly
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 Name: dB4C7 mAb

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 28 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.

Eligibility

Eligibility

Ages Eligible for Study: 20 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02369146

Locations

Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 11217

Sponsors and Collaborators

United BioPharma
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

Principal Investigator: Wing Wai Wong, M.D. Taiwan, Taipei Veterans General Hospital
Principal Investigator: Yen Hsu Chen, M.D. PhD. Kaohsiung Medical University Chung-Ho Memorial Hospital
Principal Investigator: Hung Chin Tsai, M.D. PhD. Taiwan, Kaohsiung Veterans General Hospital
More Information

More Information


Responsible Party: United BioPharma  
ClinicalTrials.gov Identifier: NCT02369146   History of Changes  
Other Study ID Numbers: UBP-A202-HIV  
Study First Received: February 5, 2015  
Last Updated: August 2, 2016  

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.