1100.1526 Phase III Switch Nevirapine IR to XR in HIV Patients

• Research type

  Research Study

• Full title

  An open label, phase IIIb, randomized parallel group study to assess the efficacy and safety of switching HIV-1 infected patients successfully treated with a Nevirapine IR based regimen to Nevirapine XR 400mg QD or remaining on Nevirapine IR 200 mg BID based regimen.

• IRAS ID

  7703

• Contact name

  Chloe Orkin

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2008-004681-55

• ISRCTN Number

  Not received

• Research summary

  This is a study in HIV-1 infected patients who are already undergoing treatment. The purpose of this study is to demonstrate the efficacy and safety of switching to nevirapine extended release (NVP XR) formulation in a population of treatment-experienced , HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) formulation. The patients must have been on Nevirapine immediate release therapy for at least 18 prior weeks prior to taking part in the study. They must also be on one of three background therapies. At baseline patients will be stratified according to their background therapy.The purpose of NVP XR is to provide patients with the option of a more convenient frequency of administration of HIV antiretroviral therapy.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  08/H0720/115

• Date of REC Opinion

  5 Nov 2008

• REC opinion

  Further Information Favourable Opinion