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

NCT01668043 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-08-20

No results posted yet for this study

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.

Conditions

  • HIV-1 Infection in Adults

Interventions

DRUG

Antibody UB-421

UB-421 is administered by intravenous infusion

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • UBI Asia in Taiwan

    collaborator UNKNOWN

  • United Biomedical

    lead INDUSTRY

Principal Investigators

  • Wing Wai Wong, M.D. · Taipei Veterans General Hospital (TVGH)

  • Hung Chin Tsai, M.D. · Kaohsiung Veterans General Hospital (KVGH)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01668043 on ClinicalTrials.gov