Status:
COMPLETED
Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults
Lead Sponsor:
United Biomedical
Conditions:
HIV-1 Infection in Adults (Asymptomatic)
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01140126
Start Date
May 1 2010
End Date
July 1 2011
Last Update
July 11 2011
Active Locations (2)
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1
Taipei Veterans General Hospital (TVGH)
Taipei, Beitou District, Taiwan, 11217
2
Kaohsiung Veterans General Hospital (KVGH)
Kaohsiung City, Zuoying District, Taiwan, 81362