Continued access darunavir/ritonavir DRV/rtv HIV-1 infected children

• Research type

  Research Study

• Full title

  Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and above.

• IRAS ID

  51991

• Contact name

  Steven Welch

• Sponsor organisation

  Tibotec Pharmaceuticals

• Eudract number

  2009-017013-29

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  This is a continued access trial for paediatric subjects who have completed treatment with DRV in the clinical trials TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-C230 sponsored by Tibotec Pharmaceuticals, and who continue to benefit from the use of DRV.At the baseline visit, inclusion and exclusion criteria will be checked to confirm eligibility. Once the eligibility criteria are met, subjects will continue treatment as follows:HIV-1 infected subjects participating in the TMC114-TiDP29-C230 trial will continue on the q.d. DRV/rtv dosing regimen as administered in the original trial.HIV-1 infected subjects participating in the TMC114-C212 or TMC114-TiDP29-C228 trial will continue on the selected b.i.d. DRV/rtv dosing regimen as administered in the original trial, or on an adjusted dose if necessary due to a confirmed (by 2 consecutive visits) change in body weight.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/22

• Date of REC Opinion

  8 Jul 2010

• REC opinion

  Further Information Favourable Opinion