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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01258374
First received: December 10, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 10, 2010
December 10, 2010
January 2010
December 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.
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

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.

Hypothesis

  • 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.

Objectives:

  • 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

HIV Integrase, HIV Protease.
  • Drug: Raltegravir
    Raltegravir 400 mg bid
    Other Name: Isentress
  • Drug: Darunavir
    Darunavir 800 mg QD + ritonavir 100 mg QD
    Other Name: Prezista, Norvir.
Dual
Dual therapy RAL 400 mg bid + DRV/r 800/100 mg QD
Interventions:
  • Drug: Raltegravir
  • Drug: Darunavir
Martínez-Rebollar M, Muñoz A, Pérez I, Hidalgo S, Brunet M, Laguno M, González A, Calvo M, Loncà M, Blanco JL, Martínez E, Gatell JM, Mallolas J. Pharmacokinetic study of dual therapy with raltegravir 400 mg twice daily and Darunavir/Ritonavir 800/100 mg once daily in HIV-1-infected patients. Ther Drug Monit. 2013 Aug;35(4):552-6. doi: 10.1097/FTD.0b013e31828d50ef.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Josep Mallolas, MD, PhD +342275400 mallolas@clinic.ub.es
Contact: Maria Martinez, MD +342275400 mmartinez@clinic.ub.es
Spain
 
NCT01258374
RALDAR-HCB
No
Principal Investigator, Josep Mallolas Masferrer
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Josep Mallolas, MD, PhD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP