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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-07-31

Brief Summary

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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 when administered to asymptomatic HIV-1 infected adults by intravenous infusion 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.

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Detailed Description

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Conditions

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HIV-1 Infection in Adults (Asymptomatic)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibody (UB-421)

Group Type EXPERIMENTAL

Antibody UB-421

Intervention Type DRUG

Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.

Interventions

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Antibody UB-421

Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Asymptomatic, treatment-naive, HIV-1 seropositive
* CD4+ T cell count \>350 cells/cubic millimeter
* HIV-1 viral load \>5,000 copies/mL

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No