Phase I study of modified dose of saquinavir and ritonavir in HIV

• Research type

  Research Study

• Full title

  To determine the effect of the modified SQV/r (saquinavir boosted by ritonavir) regimen (500/100 mg for the 1st week followed by 1000/100 mg for the 2nd week) on the QTc interval, pharmacokinetics, and antiviral activity in treatment-naïve HIV-1 infected patients.

• IRAS ID

  90824

• Contact name

  Marta Boffito

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2011-000188-28

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  HIV continues to be a major, global medical problem. Saquinavir is a potent inhibitor of HIV-1 viral protease and was the first Protease Inhibitor (PI) approved for the treatment of HIV. Two formulations of Saquinavir are currently available for oral administration; the approved dose of Saquinavir is 1000 mg twice a day (bid) plus 100 mg bid Ritonavir (SQV/r). Results of a previous study in healthy volunteers showed changes in the electrical activity patterns of the heart with the approved dose of SQV/r. Dedicated electrical activity studies of other PIs have not shown such degree of changes. Given these findings, the European Medicines Agency requested a reduced dose 500 mg/100 mg bid for seven days followed by the standard dose for patients starting treatment with SQV/r for the first time. This dosing regimen has been approved in the EU. The purpose of this study is to see if HIV patients can safely start taking SQV/r reduced dose and the effect this has on changes in the electrical activity patterns of their heart. 24 participants will take part from 1 site in the UK. This is an open label study with one treatment arm, participants will start SQV/r low dose for 7 days followed by SQV/r standard dose for 7 days. They will receive the SQV/r regimen in combination with two nucleoside reverse transcriptase inhibitors, in line with current clinical HIV treatment guidelines, for the first 14 days. Study procedures include vital signs, ECG recordings, laboratory tests, and side effects experienced during the study. A 28-day screening period is followed by a 2-week treatment period. There are 7 study visits of which 5 will be inpatient visits. After Day 14, participants may continue to receive SQV/r on prescription or another anti-HIV treatment may be prescribed by their doctor inline with current guidelines.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/1753

• Date of REC Opinion

  30 Nov 2011

• REC opinion

  Further Information Favourable Opinion