Status:
COMPLETED
Pharmacokinetic and Safety Study of Raltegravir and Atazanavir in a Once Daily Dose Regimen in HIV-1 Infected Patients
Lead Sponsor:
Radboud University Medical Center
Conditions:
HIV Infection
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00943540
Start Date
July 1 2009
End Date
January 1 2011
Last Update
November 12 2020
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Bonn
Bonn, Germany
2
Rijnstate Hospital Arnhem
Arnhem, Netherlands
3
Radboud University Medical Centre Nijmegen
Nijmegen, Netherlands
4
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands