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To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults

NCT02369146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-10-31

No results posted yet for this study

Summary

The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression.

Conditions

  • HIV-1 Infection

Interventions

DRUG

UB-421

The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • United BioPharma

    lead INDUSTRY

Principal Investigators

  • Wing Wai Wong, M.D. · Taiwan, Taipei Veterans General Hospital

  • Yen Hsu Chen, M.D. PhD. · Kaohsiung Medical University Chung-Ho Memorial Hospital

  • Hung Chin Tsai, M.D. PhD. · Taiwan, Kaohsiung Veterans General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT02369146 on ClinicalTrials.gov