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

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection; HIV Infections

Intervention: raltegravir QD (Drug); atazanavir (Drug); lamivudine (or emtricitabine) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
David Burger, Principal Investigator, Affiliation: Radboud University

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.

Clinical Details

Official title: Pharmacokinetic and Safety Pilotstudy of RAltegravir and Atazanavir in a Once DAily Dose Regimen in HIV-1 Infected Patients (PRADA)

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pharmacokinetics of raltegravir

Secondary outcome:

Viral load

Adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

University of Bonn, Bonn, Germany

Rijnstate Hospital Arnhem, Arnhem, Netherlands

Radboud University Medical Centre Nijmegen, Nijmegen, Netherlands

Erasmus Medical Center Rotterdam, Rotterdam, Netherlands

Additional Information

Starting date: July 2009
Last updated: January 7, 2011

Page last updated: August 23, 2015

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