A Phase IIa, Open-label, Multiple-Dose Trial to Investigate the Safety and Efficacy of the UB-421 in Asymptomatic HIV-1 Infected Adults
Overview
- Phase
- Phase 2
- Intervention
- Antibody UB-421
- Conditions
- HIV-1 Infection in Adults
- Sponsor
- United Biomedical
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Antibody UB-421 Cohort 1
10 mg/kg BW, 8 weekly doses for 8-week treatment period
Intervention: Antibody UB-421
Antibody UB-421 Cohort 2
25 mg/kg BW, 4 biweekly doses for 8-week treatment period
Intervention: Antibody UB-421
Outcomes
Primary Outcomes
To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421
Time Frame: 16-week study period
Safety evaluations include physical examination, measurement of vital signs, clinical chemistry and hematology tests at each visit (to assess changes from normal range), incidence of adverse event (AE) and serious AE (SAE) of two dose cohorts and are followed for 16 weeks (end of study). Overall treatment tolerability of UB-421 for each cohort is defined as the percentage of the number of actual infusion doses divided by number of actual infusion doses plus number of missed doses of subject(s) who drops out due to drug-related AE(s); calculation follows specific formula.
To evaluate efficacy by measurement of individual maximal viral load reduction and mean maximal viral load reduction of two dose cohorts of UB-421.
Time Frame: 16-week study period
Efficacy measurements include virologic responses and determination of the proportion of subjects with viral load \<50 copies/mL or \<200 copies/mL; viral load reduction \>0.5 log10 copies/mL or \>1.0 log10 copies/mL; viral rebound over 0.5 log10 increase in viral load from the nadir value during 8-week treatment period, suggesting presence of study drug resistance mutants. HIV-1 viral load is determined at each blood collection during 16-week study period.
Secondary Outcomes
- To determine pharmacokinetic parameters of two dose cohorts of UB-421.(16-week study period)
- To determine the anti-UB-421 antibody concentration in serum of two dose cohorts of UB-421(16-week study period)