Pharmacokinetic and safety pilotstudy of RAltegravir and atazanavir in a once DAily dose regimen in HIV-1 in-fected patients (PRADA) - PRADA

niversitair Medisch Centrum Sint Radboud0 sites15 target enrollmentStarted: TBDLast updated: May 6, 2024

Conditions

Trial Snapshot

No summary available.

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

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

Sponsor

niversitair Medisch Centrum Sint Radboud