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

Radboud University Nijmegen Medical Centre0 个研究点目标入组 20 人开始时间: 2009年11月24日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.
•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.

发起方

Radboud University Nijmegen Medical Centre