Clinical trial NCT01668043: Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults
Official title: A Phase IIa, Open-label, Multiple-Dose Trial to Investigate the Safety and Efficacy of the UB-421 in Asymptomatic HIV-1 Infected Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1 Infection in Adults
Keywords: HIV-1
CD4
antibody
immunotherapy
Lead sponsor: United Biomedical
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: Kaohsiung Veterans General Hospital.
name: UBI Asia in Taiwan
First posted: 2012-08-17
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421
timeFrame: 16-week study period
measure: To evaluate efficacy by measurement of individual maximal viral load reduction and mean maximal viral load reduction of two dose cohorts of UB-421.
timeFrame: 16-week study period
Secondary outcomes:
measure: To determine pharmacokinetic parameters of two dose cohorts of UB-421.
timeFrame: 16-week study period
measure: To determine the anti-UB-421 antibody concentration in serum of two dose cohorts of UB-421
timeFrame: 16-week study period
Other outcomes:
measure: To determine pharmacokinetic parameters of two dose cohorts of UB-421
timeFrame: 16-week study period
measure: To evaluate safety of multiple intravenous infusions of two dose cohorts of UB-421
timeFrame: 16-week study period
measure: To evaluate efficacy by measurement of individual viral load samples for appearance of drug resistance mutants in the two dose cohorts of UB-421
timeFrame: 16-week period
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital (TVGH)
state: Beitou District
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital (KVGH)
state: Zuoying District
Study officials:
affiliation: Taipei Veterans General Hospital (TVGH)
name: Wing Wai Wong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaohsiung Veterans General Hospital (KVGH)
name: Hung Chin Tsai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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