Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults

This study has been completed.
Sponsor:
Information provided by:
United Biomedical
ClinicalTrials.gov Identifier:
NCT01140126
First received: June 7, 2010
Last updated: July 7, 2011
Last verified: July 2011
  Purpose

The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.


Condition Intervention Phase
HIV-1 Infection in Adults (Asymptomatic)
Drug: Antibody UB-421
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults

Resource links provided by NLM:


Further study details as provided by United Biomedical:

Primary Outcome Measures:
  • To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421. [ Time Frame: Screen, treatment & follow-up: 62 to 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421. [ Time Frame: Screen, treatment & follow-up: 62 to 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibody (UB-421) Drug: Antibody UB-421
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.
Other Name: N.A.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asymptomatic, treatment-naive, HIV-1 seropositive
  • CD4+ T cell count >350 cells/cubic millimeter
  • HIV-1 viral load >5,000 copies/mL
  • Other inclusion criteria apply

Exclusion Criteria:

  • Active infection requiring immediate therapy (except HIV-1)
  • Prior participation in any HIV vaccine trial
  • Previous exposure to a monoclonal antibody
  • Use of immunomodulating drugs or systemic chemotherapy
  • Other exclusion criteria apply
  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: NCT01140126

Locations
Taiwan
Taipei Veterans General Hospital (TVGH)
Taipei City, Beitou District, Taiwan, 11217
Kaohsiung Veterans General Hospital (KVGH)
Kaohsiung City, Zuoying District, Taiwan, 81362
Sponsors and Collaborators
United Biomedical
Investigators
Principal Investigator: Wing Wai Wong, M.D. Taipei Veterans General Hospital (TVGH), Taiwan
Principal Investigator: Hung Chin Tsai, M.D. Kaohsiung Veterans General Hospital (KVGH), Taiwan
  More Information

Additional Information:
Publications:
Responsible Party: Wing Wai Wong, M.D., Taipei Veterans General Hospital (TVGH), Taiwan
ClinicalTrials.gov Identifier: NCT01140126     History of Changes
Other Study ID Numbers: UBI Protocol A101, Protocol A101-HIV
Study First Received: June 7, 2010
Last Updated: July 7, 2011
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by United Biomedical:
HIV-1, CD4, antibody, immunotherapy

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014