Once daily darunavir in adolescents

• Research type

  Research Study

• Full title

  A Phase II, open-label trial, to evaluate pharmocokinetics, safety, tolerability and antiviral activity of DRV/rtv once daily in treatment-naive HIV-1 infected adolescents aged between 12 and <18 years. This trial will be referred to as DIONE.

• IRAS ID

  21515

• Contact name

  Paddy McMaster

• Eudract number

  2008-004631-37

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  This is a 48-week, open-label, single-arm, Phase II trial to evaluate pharmacokinetics, safety, tolerability, and efficacy of darunavir with low-dose ritonavir (DRV/rtv) administered once daily (q.d.), in combination with an investigator-selected background regimen consisting of 2 NRTIs, in treatment-naive HIV-1 infected adolescents aged from 12 to < 18 years and weighing at least 40 kg. A total of 12 male and female antiretroviral (ARV) treatment-naive adolescents are planned to be included in the trial. Subjects will be considered treatment-naive if they have never received treatment with an ARV drug, including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for the treatment of hepatitis B infection with anti-HIV activity (e.g., adefovir, lamivudine, emtricitabine, entecavir). Subjects will receive the recommended dose of DRV/rtv for treatment naive HIV-1 infected adults, i.e., 800/100 mg q.d., in combination with an investigator-selected background regimen for 48 weeks. The investigator-selected background regimen will be either zidovudine (AZT)/lamivudine (3TC) or abacavir (ABC)/3TC, whichever is approved and marketed or considered local standard of care for adolescents aged from 12 to < 18 years in a particular country. Statistical analyses will be performed at Week 24 (primary analysis) and Week 48 (final analysis). Safety and tolerability will be monitored and documented throughout the trial and will be assessed by the DSMB.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/31

• Date of REC Opinion

  7 Aug 2009

• REC opinion

  Further Information Favourable Opinion