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

Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2009年5月1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 the first dosing.
•3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
•4. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes in-cluded.
•5. HIV-1 RNA < 40 copies/mL for at least 6 months on antiretroviral therapy.
•6. 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 > 3 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, didanosine, tenofovir, efavirenz, nevirapine, antacids, clarithromycin, phenytoin, phenobarbital, carbamazepine.
•7. Active hepatobiliary or hepatic disease.
•8. Alcohol abuse.

发起方

Radboud University Nijmegen Medical Centre