Phase 3b Trial of ATV Powder boosted with RTV in HIV-infected children

• Research type

  Research Study

• Full title

  A Prospective Single Arm, Open-Label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral, Naive and Experienced Pediatric Subjects Greater Than or Equal to 3 Months to Less Than 8 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE II study)

• IRAS ID

  78270

• Sponsor organisation

  BMS

• Eudract number

  2010-024537-23

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  TBD

• Research summary

  Human Immune deficiency Virus (HIV) causes progressive failure of the immune system and allows life-threatening infections and cancers to thrive. Atazanavir works by helping to prevent the virus from replicating. Atazanavir, trade name Reyataz© capsules are already approved for doctors to prescribe in combination with other recommended treatments for HIV in patients aged 6 years and older. As children can experience difficulties swallowing capsules the treatment options can be limited. This study will investigate whether Atazanavir powder is safe and tolerable when used in combination with Ritonavir and other recommended treatments. This study also aims to confirm that the dose of Atazanavir given, produces levels of medication in the blood of infants and children that are similar to those seen in adults, and that the drug is effective in fighting HIV.Patients who are aged between 3 months to 7.5 Years with HIV who meet all the study criteria will enter the study and receive Atazanavir, Ritonavir and two extra drugs called Nucleoside reverse transcription inhibitors chosen by the study doctor. Patients will undergo: physical examinations, multiple blood tests and heart-functions tests. Patients will be continually monitored and their treatment stopped if they do not respond or are unable to tolerate any side effects. The duration of time on the study will depend on the patients age and weight. When patients reach an age or weight upper limit they will stop taking Atazanavir powder and begin taking Atazanavir capsules. At this point participation in the trial will end. The study doctor may decide to continue treatment with these medications as long as they are working. Approximately 75 patients worldwide and 2 patients in the UK are expected to participate. The study is funded by Bristol Myers Squibb. Globally, the study will start in June 2011

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/YH/0144

• Date of REC Opinion

  7 Jun 2011

• REC opinion

  Further Information Favourable Opinion