IAVI LONG TERM FOLLOW-UP STUDY

• Research type

  Research Study

• Full title

  Long Term Follow-up of Study Participants from IAVI-Sponsored Clinical Trials with HIV Preventive Gene Transfer (GT) Products

• IRAS ID

  167458

• Contact name

  Daryl Bendel

• Contact email

  daryl@xideasolutions.com

• Duration of Study in the UK

  6 years, 11 months, 31 days

• Research summary

  The purpose of the Long Term Follow-up Study is to collect data on the health status of prior participants in IAVI-sponsored studies of HIV preventive gene transfer (GT) products and to characterize level and duration of expression of the transgene and sustained immunological responses. These data will provide additional information about the potential long-term risks associated with the use of these products by extending the monitoring period for previously unknown risks. The study is a prospective observational study. No investigational product will be given.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  14/SC/1362

• Date of REC Opinion

  1 Dec 2014

• REC opinion

  Further Information Favourable Opinion