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

This study has been completed.
Sponsor:
Information provided by:
United Biomedical
ClinicalTrials.gov Identifier:
NCT01140126
First received: June 7, 2010
Last updated: July 7, 2011
Last verified: July 2011

June 7, 2010
July 7, 2011
May 2010
July 2011   (final data collection date for primary outcome measure)
To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421. [ Time Frame: Screen, treatment & follow-up: 62 to 90 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01140126 on ClinicalTrials.gov Archive Site
To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421. [ Time Frame: Screen, treatment & follow-up: 62 to 90 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults
A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection in Adults (Asymptomatic)
Drug: Antibody UB-421
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.
Other Name: N.A.
Experimental: Antibody (UB-421)
Intervention: Drug: Antibody UB-421
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2011
July 2011   (final data collection date for primary outcome measure)

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 exclusion criteria apply
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01140126
UBI Protocol A101, Protocol A101-HIV
Yes
Wing Wai Wong, M.D., Taipei Veterans General Hospital (TVGH), Taiwan
United Biomedical
Not Provided
Principal Investigator: Wing Wai Wong, M.D. Taipei Veterans General Hospital (TVGH), Taiwan
Principal Investigator: Hung Chin Tsai, M.D. Kaohsiung Veterans General Hospital (KVGH), Taiwan
United Biomedical
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP