TMC278-TiDP6-C222

• Research type

  Research Study

• Full title

  An open-label trial with TMC278 25 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected subjects, who participated in TMC278 clinical trials.

• IRAS ID

  67362

• Contact name

  Chloe Orkin

• Sponsor organisation

  Tibotec Pharmaceuticals

• Eudract number

  2010-021209-18

• ISRCTN Number

  n/a

• Research summary

  The new drug TMC278 is under development for the treatment of patients infected with the human immunodeficiency virus (HIV, which in humans may lead to acquired immune deficiency syndrome (AIDS)). TMC278 is from a class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which help to slow or stop the growth of HIV. TMC278 does not yet have approval for use to treat HIV infection. Therefore, it can only be used in a research study. This study is designed to provide continued access to TMC278 for patients who were previously randomized and treated with TMC278 in the Phase IIb and Phase III trials, and who continue to benefit from the treatment, in the opinion of the study doctor. In addition, information on the long-term safety and tolerability (how well the body tolerates the drug) of oral doses of TMC278 25mg q.d. (once daily) in combination with a background regimen containing 2 N(t)RTIs will be collected. Available efficacy data will also be collected. It is anticipated that approximately 750 people will participate in this study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/H0605/6

• Date of REC Opinion

  29 Mar 2011

• REC opinion

  Further Information Favourable Opinion