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

Phase 1

Completed

• Conditions: HIV-1 Infection in Adults (Asymptomatic)
• Interventions: Drug: Antibody UB-421

• Registration Number: NCT01140126
• Lead Sponsor: United Biomedical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-09
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-07
• Last Update Posted: 2011-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

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
• Other exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antibody (UB-421)	Antibody UB-421	-

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.	Screen, treatment & follow-up: 62 to 90 days

Secondary Outcome Measures

Name	Time	Method
To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421.	Screen, treatment & follow-up: 62 to 90 days

Trial Locations

Locations (2)

Kaohsiung Veterans General Hospital (KVGH); 🇨🇳 Kaohsiung City, Zuoying District, Taiwan

Taipei Veterans General Hospital (TVGH); 🇨🇳 Taipei City, Beitou District, Taiwan