Continued access to etravirine - TMC125C239

• Research type

  Research Study

• Full title

  Continued access to etravirine in treatment experienced HIV-1 infected children and adolescents.

• IRAS ID

  30592

• Contact name

  Steven Welch

• Sponsor organisation

  Tibotec Pharmaceuticals Ltd

• Eudract number

  2009-013126-16

• ISRCTN Number

  n/a

• Research summary

  This is a continued access trial for subjects who have completed treatment in a pediatric clinical trial with etravirine sponsored by or in collaboration with Tibotec and who continue to benefit from the use of etravirine. At the baseline visit, inclusion/exclusion criteria will be checked to confirm eligibility. Once eligibility criteria are met, subjects will either continue on the etravirine dose they have received in the previous etravirine trial or on an adjusted dose if deemed necessary by the investigator. Etravirine dose adjustment will be based onweight using the dosing guidelines provided. Assessment visits are recommended every three months. Adverse events leading to treatment interruption or discontinuation, adverse events at least possibly related to treatment with etravirine, serious adverse events, and pregnancies will be recorded at each visit. Additional assessments not included in this protocol can be done locally at the Investigator's discretion as per local standard of care. Treatment will be continued until one of the following criteria is met: the investigator determines that the subject no longer benefits from etravirine treatment (e.g., based on viral load); treatment limiting toxicity; loss to follow-up; patient withdrawal of consent; pregnancy; termination of the program by the Sponsor; etravirine becomes commercially available for pediatric use, is reimbursed, or can be accessed through another source (e.g. access program, government program) in the region the subject is living in, whichever occurs first.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/112

• Date of REC Opinion

  9 Nov 2009

• REC opinion

  Further Information Favourable Opinion