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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01668043
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : August 20, 2014
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
Kaohsiung Veterans General Hospital.
UBI Asia in Taiwan
Information provided by (Responsible Party):
United Biomedical

Tracking Information
First Submitted Date  ICMJE August 1, 2012
First Posted Date  ICMJE August 17, 2012
Last Update Posted Date August 20, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2012)
  • To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421 [ Time Frame: 16-week study period ]
    Safety evaluations include physical examination, measurement of vital signs, clinical chemistry and hematology tests at each visit (to assess changes from normal range), incidence of adverse event (AE) and serious AE (SAE) of two dose cohorts and are followed for 16 weeks (end of study). Overall treatment tolerability of UB-421 for each cohort is defined as the percentage of the number of actual infusion doses divided by number of actual infusion doses plus number of missed doses of subject(s) who drops out due to drug-related AE(s); calculation follows specific formula.
  • To evaluate efficacy by measurement of individual maximal viral load reduction and mean maximal viral load reduction of two dose cohorts of UB-421. [ Time Frame: 16-week study period ]
    Efficacy measurements include virologic responses and determination of the proportion of subjects with viral load <50 copies/mL or <200 copies/mL; viral load reduction >0.5 log10 copies/mL or >1.0 log10 copies/mL; viral rebound over 0.5 log10 increase in viral load from the nadir value during 8-week treatment period, suggesting presence of study drug resistance mutants. HIV-1 viral load is determined at each blood collection during 16-week study period.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2012)
  • To determine pharmacokinetic parameters of two dose cohorts of UB-421. [ Time Frame: 16-week study period ]
    Pharmacokinetic analyses are calculated at each visit during 8-week treatment period to determine the serum concentration before and after each infusion of UB-421 and during the 8-week follow-up period to determine the clearance of study drug in circulation.
  • To determine the anti-UB-421 antibody concentration in serum of two dose cohorts of UB-421 [ Time Frame: 16-week study period ]
    Immunogenicity of the study drug is measured by analytical ELISA test at each visit to determine if the anti-UB-421 antibody concentration is increased above the pre-treatment baseline level.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 20, 2012)
  • To determine pharmacokinetic parameters of two dose cohorts of UB-421 [ Time Frame: 16-week study period ]
    Pharmacokinetic analyses are calculated at each visit during 8-week treatment period to determine the percentage of CD4+ T lymphocytes binding to the UB-421 study drug before each infusion and during the 8-week follow-up period to determine the duration of study drug bound to the CD4+ cells in circulation
  • To evaluate safety of multiple intravenous infusions of two dose cohorts of UB-421 [ Time Frame: 16-week study period ]
    Safety evaluations include evaluation of peripheral blood mononuclear cell proliferation and expression of Th1 and Th2 cytokines in the presence of study drug before the first and last UB-421 infusions during 8-week treatment period and at the end of follow-up period.
  • To evaluate efficacy by measurement of individual viral load samples for appearance of drug resistance mutants in the two dose cohorts of UB-421 [ Time Frame: 16-week period ]
    Efficacy measurements include virologic responses and determination of the proportion of subjects (if any) with viral load rebound during 8-week treatment period, suggesting emergence of study drug resistance mutants. Samples with viral load rebound will be characterized further to identify virus mutation(s).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults
Official Title  ICMJE A Phase IIa, Open-label, Multiple-Dose Trial to Investigate the Safety and Efficacy of the UB-421 in Asymptomatic HIV-1 Infected Adults
Brief Summary The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected adults 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection in Adults
Intervention  ICMJE Drug: Antibody UB-421
UB-421 is administered by intravenous infusion
Study Arms  ICMJE
  • Experimental: Antibody UB-421 Cohort 1
    10 mg/kg BW, 8 weekly doses for 8-week treatment period
    Intervention: Drug: Antibody UB-421
  • Experimental: Antibody UB-421 Cohort 2
    25 mg/kg BW, 4 biweekly doses for 8-week treatment period
    Intervention: Drug: Antibody UB-421
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2014)
29
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2012)
20
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  • Previous exposure to monoclonal antibody (including UB-421)
  • Prior participation in any HIV vaccine trial
  • Use of immunomodulating drugs or systemic chemotherapy
  • Other exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01668043
Other Study ID Numbers  ICMJE UBI Protocol A201
Protocol A201-HIV ( Other Identifier: UBI Asia )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party United Biomedical
Original Responsible Party Same as current
Current Study Sponsor  ICMJE United Biomedical
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Taipei Veterans General Hospital, Taiwan
  • Kaohsiung Veterans General Hospital.
  • UBI Asia in Taiwan
Investigators  ICMJE
Principal Investigator: Wing Wai Wong, M.D. Taipei Veterans General Hospital (TVGH)
Principal Investigator: Hung Chin Tsai, M.D. Kaohsiung Veterans General Hospital (KVGH)
PRS Account United Biomedical
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP