Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients. (RALDAR)
|ClinicalTrials.gov Identifier: NCT01258374|
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment|
|HIV Integrase, HIV Protease.||Drug: Raltegravir Drug: Darunavir|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|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|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||December 2011|
Single arm with dual therapy
Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD
Raltegravir, 400 mg bid
Other Name: Isentress
Darunavir, 800 mg QD + ritonavir 100 mg QD
Other Name: Prezista, Norvir.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258374
|Barcelona, Spain, 08036|
|Principal Investigator:||Josep Mallolas, MD, PhD||Hospital Clinic of Barcelona|