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Pharmacokinetic and Safety Study of Raltegravir and Atazanavir in a Once Daily Dose Regimen in HIV-1 Infected Patients (PRADA)

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: NCT00943540
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : January 10, 2011
Information provided by:
Radboud University

Brief Summary:

The licensed dose of raltegravir is 400 mg twice daily with or without food. Raltegravir is metabolized predominantly through glucuronidation by UGT1A1. Atazanavir increases the plasma concentrations of raltegravir 400 mg twice daily by 72% due to inhibition of UGT 1A1.

This suggests that combined use of atazanavir and a lower dose frequency of raltegravir, once daily for example, is possible. Another reason why raltegravir most likely can be applied is that its pharmacodynamic effect is not related to Cmin but to AUC which is expected to be similar for an 800mg QD dose when compared to 400mg BD. Phase III clinical trials evaluating QD dosing of raltegravir are currently ongoing and interim results are expected to be published in mid 2009.

A regimen of atazanavir and raltegravir in combination with lamivudine or emtricitabine may be a well tolerated and effective NNRTI-, and ritonavir-sparing regimen that could be an attractive option for both first and second line (after NRTI/NNRTI failure) treatment regimens.

Condition or disease Intervention/treatment Phase
HIV Infection HIV Infections Drug: raltegravir QD Drug: atazanavir Drug: lamivudine (or emtricitabine) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Safety Pilotstudy of RAltegravir and Atazanavir in a Once DAily Dose Regimen in HIV-1 Infected Patients (PRADA)
Study Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Raltegravir BID-QD

Week 1-4

  • 600 mg of atazanavir to be taken once daily
  • 400 mg of raltegravir to be taken twice daily
  • 300 mg of lamivudine (or 200 mg of emtricitabine) to be taken once daily

Week 5-8

  • 600 mg of atazanavir to be taken once daily
  • 800 mg of raltegravir to be taken once daily
  • 300 mg of lamivudine (or 200 mg of emtricitabine) to be taken once daily
Drug: raltegravir QD
Raltegravir 800mg QD

Drug: atazanavir

Drug: lamivudine (or emtricitabine)
lamivudine (or emtricitabine)

Primary Outcome Measures :
  1. pharmacokinetics of raltegravir [ Time Frame: after two weeks of reference treatment and after two weeks of test treatment ]

Secondary Outcome Measures :
  1. Viral load [ Time Frame: after two weeks treatment with the reference treatment and after two weeks treatment with the test treatment ]
  2. Adverse events [ Time Frame: entire trial ]

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
  • Subject is at least 18 years of age at the day of screening.
  • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
  • HIV-1 RNA < 40 copies/mL for at least 6 months on antiretroviral therapy.
  • Subject has no history of previous virological failure or documented resistance mutations

Exclusion Criteria:

  • History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.
  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female.
  • Abnormal serum transaminases determined as levels being > 5 times upper limit of normal (see Appendix A for normal ranges of clinical laboratory values).
  • Concomitant use of medications that interfere with raltegravir or atazanavir pharmacokinetics: rifampicin, irinotecan, midazolam, triazolam, ergotamine, dihydroergotamine, cisapride, pimozide, lovastatin, simvastatin, indinavir, proton pump inhibitors, H2 receptor antagonists, St. john's wort, Ginkgo Biloba, didanosine, tenofovir, efavirenz, nevirapine, antacids, clarithromycin, phenytoin, phenobarbital, carbamazepine.
  • Active hepatobiliary or hepatic disease (including chronic hepatitis B infection).
  • Alcohol abuse.

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): NCT00943540

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University of Bonn
Bonn, Germany
Rijnstate Hospital Arnhem
Arnhem, Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen, Netherlands
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands
Sponsors and Collaborators
Radboud University
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Principal Investigator: David Burger Radboud University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: D.M. Burger, PhD, PharmD, Radboud University Medical Centre Nijmegen Identifier: NCT00943540    
Other Study ID Numbers: UMCN-AKF 08.07
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: January 2011
Keywords provided by Radboud University:
single dose
Treatment experienced
Additional relevant MeSH terms:
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Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Raltegravir Potassium
Atazanavir Sulfate
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors