NCT02369146

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

February 5, 2015

Last Update Submit

October 29, 2017

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    17 weeks for cohort 1, 25 weeks for cohort 2

Secondary Outcomes (2)

  • Peak concentration of UB-421

    8 weeks for cohort 1, 15 weeks for cohort 2

  • Trough concentration of UB-421

    8 weeks for cohort 1, 15 weeks for cohort 2

Study Arms (2)

cohort 1

EXPERIMENTAL

Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly

Drug: UB-421

cohort 2

EXPERIMENTAL

Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly

Drug: UB-421

Interventions

UB-421DRUG

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).

Also known as: dB4C7 mAb
cohort 1cohort 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 sero-positive
  • Aged 20 years or older
  • Have received HAART treatment
  • CD4+ T cell count ≧ 350 cells/mm3
  • HIV-1 plasma RNA level remains below the limit of
  • Were not breastfeeding for women
  • Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
  • Subjects agree on using birth control barrier (female or male condom) during the entire study period
  • Subjects sign the informed consent before undergoing any study procedures

You may not qualify if:

  • Any active infection except for HIV, and required immediate therapy
  • Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
  • Any documented CD4+ T cell count \< 200 cells/mm3 within the past 12 weeks before screening visit
  • Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
  • Any vaccination within 8 weeks prior to the first dose of study drug
  • Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug
  • Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug
  • Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
  • More than one change of HAART regimen because of virologic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

  • Wang CY, Wong WW, Tsai HC, Chen YH, Kuo BS, Lynn S, Blazkova J, Clarridge KE, Su HW, Lin CY, Tseng FC, Lai A, Yang FH, Lin CH, Tseng W, Lin HY, Finstad CL, Wong-Staal F, Hanson CV, Chun TW, Liao MJ. Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption. N Engl J Med. 2019 Apr 18;380(16):1535-1545. doi: 10.1056/NEJMoa1802264.

    PMID: 30995373DERIVED

MeSH Terms

Interventions

UB-421

Study Officials

  • Wing Wai Wong, M.D.

    Taiwan, Taipei Veterans General Hospital

    PRINCIPAL INVESTIGATOR

  • Yen Hsu Chen, M.D. PhD.

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Hung Chin Tsai, M.D. PhD.

    Taiwan, Kaohsiung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

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

February 5, 2015

First Posted

February 23, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

TW(1)