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

United Biomedical

Status and phase: Completed; Phase 2

Conditions: HIV-1 Infection in Adults

Treatments: Drug: Antibody UB-421

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01668043

UBI Protocol A201

Protocol A201-HIV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 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)
• Previous exposure to monoclonal antibody (including UB-421)
• Prior participation in any HIV vaccine trial
• Use of immunomodulating drugs or systemic chemotherapy
• Other exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Antibody UB-421 Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Antibody UB-421

Antibody UB-421 Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Antibody UB-421