Completed

A Phase IIa, Open-label, Multiple-Dose Trial to Investigate the Safety and Efficacy of the UB-421 in Asymptomatic HIV-1 Infected Adults

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What is being tested

Antibody UB-421

+ Antibody UB-421

Drug
Who is being recruted

Over 20 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUnited Biomedical
Last updated: August 20, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01668043
Principal SponsorUnited Biomedical
Last updated: August 20, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
Active infection requiring immediate therapy (except HIV-1)
Other exclusion criteria apply
Previous exposure to monoclonal antibody (including UB-421)
Prior participation in any HIV vaccine trial
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
10 mg/kg BW, 8 weekly doses for 8-week treatment period

Group II

Experimental
25 mg/kg BW, 4 biweekly doses for 8-week treatment period

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Taipei Veterans General Hospital (TVGH)

Taipei, TaiwanOpen Taipei Veterans General Hospital (TVGH) in Google Maps

Kaohsiung Veterans General Hospital (KVGH)

Kaohsiung City, Taiwan
Completed2 Study Centers