HIV-1 Infection in Adults (Asymptomatic)
Conditions
Keywords
HIV-1, CD4, antibody, immunotherapy
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.
Interventions
DRUGAntibody UB-421
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.
Sponsors
United Biomedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421. | Screen, treatment & follow-up: 62 to 90 days |
Countries
Taiwan
Outcome results
None listed