Opal-HIV-1001

• Research type

  Research Study

• Full title

  A phase 1, dose escalating, single centre, double blind study of the safety and immunogenicity of Opal-HIV-Gag clade C in Human Immunodeficiency Virus-type 1 (HIV 1) positive subjects.

• IRAS ID

  25232

• Contact name

  Marta Boffito

• Sponsor organisation

  Medicines Development Limited

• Eudract number

  2008-005142-23

• ISRCTN Number

  Not applicable

• Research summary

  HIV is one of the world??s most significant diseases. Despite improved prevention methods and treatment options, it remains a growing cause of morbidity and mortality worldwide. Although effective treatments for HIV infection exist, affordability, safety and long term efficacy are problematic. The first-in-human clinical trial of Opal-HIV-Gag(c) will be a single-centre, Phase I, randomised, double-blind, sequential dose-escalation, controlled study of the safety and immunogenicity of Opal-HIV-Gag(c) in HIV-1 positive subjects. This study will evaluate the safety of Opal-HIV-Gag(c) in a dose escalating design in HIV-1 positive patients. There will also be an assessment of immunogenicity. Approximately 27 subjects whose HIV disease is well controlled on antiretroviral therapy will be enrolled. The study will be open to subjects that have documented history of their HIV subtype of infection (clade). Subjects of all clades or subtypes will be eligible however; there is a particular interest in clade C subtype. The study will be completed at the Phase I unit within St Stephen??s Centre at the Chelsea & Westminster Hospital, London. This is a dedicated HIV-treatment facility with unique expertise in Phase I studies in HIV infected subjects. Opal-HIV-Gag(c) is administered ex vivo, meaning outside of the body. To do this whole blood is removed from subjects and separated into components using a cell separation device. The white blood cell component is incubated with Opal-HIV-Gag(c) for 1 hour and then reinfused into subjects. Subjects will be treated with Opal-HIV-Gag(c) or placebo on Weeks 0, 4, 8 and 12. After completion of treatment, subjects will be followed for 12 weeks to monitor safety and immune responses for a total of 24 weeks participation.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  10/H0801/1

• Date of REC Opinion

  9 Feb 2010

• REC opinion

  Favourable Opinion