Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients. (RALDAR)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Dual Therapy With Raltegravir 400 mg BID and Darunavir/Ritonavir 800/100 mg QD in HIV Infected Patients Failing to Nucleoside Reverse Transcriptase Inhibitors Based Regimens|
|Study Start Date:||May 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Single arm with dual therapy
Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD
Raltegravir, 400 mg bid
Other Name: IsentressDrug: Darunavir
Darunavir, 800 mg QD + ritonavir 100 mg QD
Other Name: Prezista, Norvir.
- NRTI-sparing regimens are attractive options to avoid NRTI-associated toxicity and to provide a full active regimen in patients with some extent of NRTI resistance.
- Raltegravir (RAL) and Darunavir (DRV) are potent "third drugs" and they provide a synergistic inhibition of 2 different steps in HIV replication.
- DRV has a high genetic barrier, and could be an excellent accompanying drug for Raltegravir, providing a potent, safe and well tolerated dual therapy to patients who are failing NNRTI based treatments.
- To describe the safety, tolerability and efficacy of the combination of Raltegravir and Darunavir after 24 weeks of follow up in HIV infected patients failing a NRTI based regimen.
- To describe plasma pharmacokinetics of Raltegravir when combined with Darunavir 800mg QD in HIV-infected patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258374
|Barcelona, Spain, 08036|
|Principal Investigator:||Josep Mallolas, MD, PhD||Hospital Clinic of Barcelona|