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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
  Purpose

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 Intervention
HIV Integrase, HIV Protease.
 Drug: Raltegravir
Drug: Darunavir

Study Type: Observational
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dual
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.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258374

Contacts
Contact: Josep Mallolas, MD, PhD +342275400 mallolas@clinic.ub.es
Contact: Maria Martinez, MD +342275400 mmartinez@clinic.ub.es

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Josep Mallolas, MD, PhD     +342275400     mallolas@clinic.ub.es    
Principal Investigator: Josep Mallolas, MD, PhD            
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Josep Mallolas, MD, PhD Hospital Clinic Barcelona
  More Information

No publications provided

Responsible Party: Principal Investigator, Josep Mallolas Masferrer
ClinicalTrials.gov Identifier: NCT01258374     History of Changes
Other Study ID Numbers: RALDAR-HCB
Study First Received: December 10, 2010
Last Updated: December 10, 2010
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Ritonavir
Darunavir
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013