Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients. (RALDAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258374
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Josep Mallolas Masferrer, Hospital Clinic of Barcelona

Brief 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.

Condition or disease Intervention/treatment
HIV Integrase, HIV Protease. Drug: Raltegravir Drug: Darunavir

Detailed Description:


  • 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
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
Actual Primary Completion Date : May 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Single arm with dual therapy
Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD
Drug: Raltegravir
Raltegravir, 400 mg bid
Other Name: Isentress

Drug: Darunavir
Darunavir, 800 mg QD + ritonavir 100 mg QD
Other Name: Prezista, Norvir.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A total of 20 HIV-infected patients failing NRTI based regimens will be included . At least 12 of these patients will undergo a complete pharmacokinetic study.

Inclusion Criteria:

  • Documented HIV infection
  • Naïve to Raltegravir.
  • CD4 cell count above 200 cell/mm3.
  • No history of failure to PI containing regimens.
  • No evidence of PI mutations (IAS-mutation list) by genotype test.
  • Failing to a NRTI based regimen.
  • The treating physician decides a NRTI sparing regimen which includes DRV/r 800/100 mg QD plus Raltegravir 400 mg BID.
  • Signed informed consent form
  • In opinion of the investigator, the patient should be considered clinically stable and could follow regular visits as scheduled per protocol.

Exclusion Criteria:

  • Patients receiving drugs considered contraindicated to Raltegravir and DRV/r. Contraindicated drugs are: rifampin, fenitoin, phenobarbital in the case of raltegravir. Pravastatin, astemizole, sildenafil, are contraindicated in combination with DRV/r.
  • Pregnancy
  • Documented PI mutations

Information from the National Library of Medicine

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 identifier (NCT number): NCT01258374

Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: Josep Mallolas, MD, PhD Hospital Clinic of Barcelona

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Josep Mallolas Masferrer, MD, PhD, Hospital Clinic of Barcelona Identifier: NCT01258374     History of Changes
Other Study ID Numbers: RALDAR-HCB
First Posted: December 13, 2010    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

Keywords provided by Josep Mallolas Masferrer, Hospital Clinic of Barcelona:
Pharmacokinetics, raltegravir, darunavir, NRTI sparing regimen

Additional relevant MeSH terms:
Raltegravir Potassium
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Nucleic Acid Synthesis Inhibitors