Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults
A Phase IIa, Open-label, Multiple-Dose Trial to Investigate the Safety and Efficacy of the UB-421 in Asymptomatic HIV-1 Infected Adults
2 other identifiers
interventional
29
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2012
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedAugust 20, 2014
August 1, 2014
1.5 years
August 1, 2012
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421
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.
16-week study period
To evaluate efficacy by measurement of individual maximal viral load reduction and mean maximal viral load reduction of two dose cohorts of UB-421.
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.
16-week study period
Secondary Outcomes (2)
To determine pharmacokinetic parameters of two dose cohorts of UB-421.
16-week study period
To determine the anti-UB-421 antibody concentration in serum of two dose cohorts of UB-421
16-week study period
Other Outcomes (3)
To determine pharmacokinetic parameters of two dose cohorts of UB-421
16-week study period
To evaluate safety of multiple intravenous infusions of two dose cohorts of UB-421
16-week study 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
16-week period
Study Arms (2)
Antibody UB-421 Cohort 1
EXPERIMENTAL10 mg/kg BW, 8 weekly doses for 8-week treatment period
Antibody UB-421 Cohort 2
EXPERIMENTAL25 mg/kg BW, 4 biweekly doses for 8-week treatment period
Interventions
UB-421 is administered by intravenous infusion
Eligibility Criteria
You may qualify if:
- Asymptomatic, treatment-naive, HIV-1 seropositive
- CD4+ T cell count \>350 cells/cubic millimeter
- HIV-1 viral load \>5,000 copies/mL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United Biomedicallead
- Taipei Veterans General Hospital, Taiwancollaborator
- Kaohsiung Veterans General Hospital.collaborator
- UBI Asia in Taiwancollaborator
Study Sites (2)
Taipei Veterans General Hospital (TVGH)
Taipei, Beitou District, 11217, Taiwan
Kaohsiung Veterans General Hospital (KVGH)
Kaohsiung City, Zuoying District, 81362, Taiwan
Related Publications (2)
Wang CY, Sawyer LS, Murthy KK, Fang X, Walfield AM, Ye J, Wang JJ, Chen PD, Li ML, Salas MT, Shen M, Gauduin MC, Boyle RW, Koup RA, Montefiori DC, Mascola JR, Koff WC, Hanson CV. Postexposure immunoprophylaxis of primary isolates by an antibody to HIV receptor complex. Proc Natl Acad Sci U S A. 1999 Aug 31;96(18):10367-72. doi: 10.1073/pnas.96.18.10367.
PMID: 10468614BACKGROUNDLynn S and Wang CY. Designed deimmunied monoclonal antibodies for protection against HIV exposure and treatment of HIV infection. U.S. Patent No. 7,501,494. http://patft.uspto.gov/netahtml/PTO/srchnum.htm
BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Wing Wai Wong, M.D.
Taipei Veterans General Hospital (TVGH)
- PRINCIPAL INVESTIGATOR
Hung Chin Tsai, M.D.
Kaohsiung Veterans General Hospital (KVGH)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 17, 2012
Study Start
September 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
August 20, 2014
Record last verified: 2014-08