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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol A201-HIV | Other Identifier | UBI Asia |
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| Name | Class |
|---|---|
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
| Kaohsiung Veterans General Hospital. | OTHER |
| UBI Asia in Taiwan | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibody UB-421 Cohort 1 | Experimental | 10 mg/kg BW, 8 weekly doses for 8-week treatment period |
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| Antibody UB-421 Cohort 2 | Experimental | 25 mg/kg BW, 4 biweekly doses for 8-week treatment period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibody UB-421 | Drug | UB-421 is administered by intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421 | 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. | 16-week study period |
| To evaluate efficacy by measurement of individual maximal viral load reduction and mean maximal viral load reduction of two dose cohorts of UB-421. | 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. | 16-week study period |
| Measure | Description | Time Frame |
|---|---|---|
| To determine pharmacokinetic parameters of two dose cohorts of UB-421. | Pharmacokinetic analyses are calculated at each visit during 8-week treatment period to determine the serum concentration before and after each infusion of UB-421 and during the 8-week follow-up period to determine the clearance of study drug in circulation. | 16-week study period |
| Measure | Description | Time Frame |
|---|---|---|
| To determine pharmacokinetic parameters of two dose cohorts of UB-421 | Pharmacokinetic analyses are calculated at each visit during 8-week treatment period to determine the percentage of CD4+ T lymphocytes binding to the UB-421 study drug before each infusion and during the 8-week follow-up period to determine the duration of study drug bound to the CD4+ cells in circulation | 16-week study period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wing Wai Wong, M.D. | Taipei Veterans General Hospital (TVGH) | Principal Investigator |
| Hung Chin Tsai, M.D. | Kaohsiung Veterans General Hospital (KVGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital (TVGH) | Taipei | Beitou District | 11217 | Taiwan | ||
| Kaohsiung Veterans General Hospital (KVGH) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10468614 | Background | Wang CY, Sawyer LS, Murthy KK, Fang X, Walfield AM, Ye J, Wang JJ, Chen PD, Li ML, Salas MT, Shen M, Gauduin MC, Boyle RW, Koup RA, Montefiori DC, Mascola JR, Koff WC, Hanson CV. Postexposure immunoprophylaxis of primary isolates by an antibody to HIV receptor complex. Proc Natl Acad Sci U S A. 1999 Aug 31;96(18):10367-72. doi: 10.1073/pnas.96.18.10367. | |
| Background | Lynn S and Wang CY. Designed deimmunied monoclonal antibodies for protection against HIV exposure and treatment of HIV infection. U.S. Patent No. 7,501,494. http://patft.uspto.gov/netahtml/PTO/srchnum.htm |
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| To determine the anti-UB-421 antibody concentration in serum of two dose cohorts of UB-421 | Immunogenicity of the study drug is measured by analytical ELISA test at each visit to determine if the anti-UB-421 antibody concentration is increased above the pre-treatment baseline level. | 16-week study period |
| To evaluate safety of multiple intravenous infusions of two dose cohorts of UB-421 | Safety evaluations include evaluation of peripheral blood mononuclear cell proliferation and expression of Th1 and Th2 cytokines in the presence of study drug before the first and last UB-421 infusions during 8-week treatment period and at the end of follow-up period. | 16-week study period |
| To evaluate efficacy by measurement of individual viral load samples for appearance of drug resistance mutants in the two dose cohorts of UB-421 | Efficacy measurements include virologic responses and determination of the proportion of subjects (if any) with viral load rebound during 8-week treatment period, suggesting emergence of study drug resistance mutants. Samples with viral load rebound will be characterized further to identify virus mutation(s). | 16-week period |
| Kaohsiung City |
| Zuoying District |
| 81362 |
| Taiwan |