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

United Biomedical

Status and phase: Completed; Phase 1

Conditions: HIV-1 Infection in Adults (Asymptomatic)

Treatments: Drug: Antibody UB-421

Study type: Interventional

Funder types: Industry

Identifiers

NCT01140126

UBI Protocol A101

Protocol A101-HIV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Antibody (UB-421)

Experimental group

Treatment:

Drug: Antibody UB-421