Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
While 3-drug regimens remain standard of care, concerns exist regarding the safety of
multi-drug regimens taken for a lifetime. Problems with nucleoside analogue therapy prompted
successful trials with ritonavir (RTV) boosted PI monotherapy, however long term safety and
efficacy of such regimens remains unknown. Clinical trials have shown Raltegravir (RAL) to
have potent activity when patients have few active background drugs; it has a superior lipid
profile compared with EFV and LPV/RTV. Darunavir/r (DRV) is a potent, well tolerated PI with
few GI side effects and lipid disturbances and with a high genetic barrier. The investigators
hypothesized that RAL/DRV would be a well tolerated and effective regimen for those patients
who are failing nucleoside reverse transcriptase inhibitors based regimens, due to poor
tolerability or resistance. The investigators also would like to explore the plasma
pharmacokinetics of Raltegravir combined with Darunavir in a sub-group of 12 HIV-infected
patients.