Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients. (RALDAR)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|