Pharmacokinetics of lopinavir/ritonavir at three different doses. v1.0

• Research type

  Research Study

• Full title

  Pharmacokinetics of plasma lopinavir/ritonavir over a 12 hour dosing interval following administration of 400/100, 200/150, and 200/50 mg twice daily to HIV-negative healthy volunteers

• IRAS ID

  23462

• Sponsor organisation

  National Centre in HIV Epidemiology & Clinical Research

• Eudract number

  2009-012513-21

• ISRCTN Number

  Not Known

• Research summary

  The purpose of this study is to assess the pharmacokinetics-(that means how a drug is absorbed, distributed and eliminated from the body) of plasma lopinavir/ritonavir over a 12 hour dosing interval following administration to male and female HIV-negative volunteers. The study will take place at Chelsea and Westminster Hospital. Measurements will be taken of pharmacokinetic profiles of lopinavir/ritonavir when administered at three different doses to twenty four male and female healthy volunteers by the following three treatment arm method: Phase 1 (7 days): Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID)Wash-out 1 (no drug for 7 days)Phase 2: Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)Wash-out 1 (no drug for 7 days)Phase 3 (7 days): Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BIDThe aim of the study is to assess how the drug is absorbed, distributed and eliminated from the body and secondly to assess the safety and tolerability of low lopinavir/ritonavir doses.The duration of the study is 35 days (excluding screening visit and follow up visits.Volunteers will visit the unit on up to 8 occasions during the 35-day study period. On 3 of these visits, volunteers will need to stay in the unit for the whole day (approximately 12 hours). There will also be a screening visit up to 4 weeks before the study starts and a follow up visit 1-2 weeks after the last dose of study medication.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/51

• Date of REC Opinion

  11 Sep 2009

• REC opinion

  Further Information Favourable Opinion