A randomised, open-label, cross-over study to examine the pharmacokinetics, and short-term safety and efficacy of two dosing strategies of raltegravir and atazanavir in HIV-infected patients (SPARTA)

Date Commenced:
07/2009
Project Status
Completed
Expected Date of Completion:
Completed
Project Supporters

UNSW

Currently recruiting
No
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About the Project

Rationale

Currently recommended antiretroviral regimens can be problematic. The availability of novel antiretroviral drug classes provides an opportunity to explore moves away from recommended regimen components.

Aims

To compare in virologically suppressed HIV-infected adults receiving atazanavir-containing combination antiretroviral therapy the steady-state pharmacokinetics and short-term safety and efficacy of two dosing strategies of raltegravir and atazanavir.

Design & Method

This is a randomised, open-label, cross-over 8-week study of two consecutive four-week dosing strategies of raltegravir plus atazanavir in HIV-infected adults. Twenty-four (24) eligible subjects currently receiving atazanavir-containing suppressive antiretroviral therapy will be recruited and randomised in a 1:1 ratio to receive raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily for 4 weeks followed by raltegravir 800 mg daily plus atazanavir 300 mg and ritonavir 100 mg daily for 4 weeks or vice versa.Following each 4 weeks of therapy, participants will have multiple (10) time point blood sampling over 12 hours for the twice daily regimen and over 24 hours for the daily regimen. Plasma concentrations of atazanavir, raltegravir and ritonavir will be determined from the serial blood samples. The study has pharmacokinetic, efficacy and safety endpoints. Individuals who remain on a study regimen at the completion of week 8 and consent to longer-term follow-up will have CD4 cells and HIV RNA measured at weeks 24 and 48.

Progress/Update

Recruitment closed, study due for completion July 2011.

Output

The study has pharmacokinetic, efficacy and safety endpoints.

Project Members
image - 1338436495 Di Carey.jpg
Clinical Project Leader
Ph +61 (2) 9385 0908
image - Handan Wand 220415
Associate Professor
Ph +61 (0)2 9385 0861
Project Attachment
Other Investigators

David Cooper, Mark Bloch, Sean Emery, Mark Boyd

Project Collaborators: External

St Vincent’s Hospital, Sydney

Holdsworth House Medical Practice, Sydney

Project Contacts

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