Pharmacokinetics, safety and efficacy of atazanavir /dolutegravir/lamivudine regimen as maintenance regimen in pa-tients with intolerance and/or resistance to NRTIs, NNRTIs and RTV: a pilot study (PRADA II study) - PRADA II

Radboud University Medical Center0 个研究点目标入组 20 人开始时间: 2015年1月19日最近更新: 2017年10月30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 in need for a switch in maintenance regimen due to adverse effects, toxicities, simplification and/or resistance.
•3.Subject is at least 18 years of age at the day of screening.
•4.Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
•5.HIV-1 RNA < 40 copies/mL for at least 6 months on antiretroviral therapy prior to inclusion.
•6.Subject has no documented resistance mutations to PIs, INSTIs or lamivudine.
•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 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1.Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
•2.Relevant history or current condition that might interfere with drug absorption, distribution, me-tabolism or excretion.
•3.Inability to understand the nature and extent of the trial and the procedures required.
•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 transaminases determined as levels being > 5 times upper limit of normal (see Appendix A for normal ranges of clinical laboratory values).
•6.Renal failure determined as an estimated Glomerular Filtration Rate (eGFR) < 50 ml/min (MDRD-based).
•7.Concomitant use of medications that interfere with atazanavir, dolutegravir or lamivudine pharma-cokinetics: oxcarbamazepine, phenytoin, phenobarbital, carbamazepine, St. John’s wort, rifam-picin, clarithromycin, H2 receptor antagonists, proton pump inhibitors, irinotecan, midazolam, triazolam, co-trimoxazole, other antiretroviral drugs.
•8.Concomitant use of medications that are contraindicated for use with atazanavir, dolutegravir or lamivudine: alfuzosin, dofetilide, quetiapine, kinidine, bepridil, simvastatin, atorvastatin, lovastatin, sildenafil (as for use in pulmonary arterial hypertension), cladribine.
•9.Active hepatobiliary or hepatic disease (including chronic hepatitis B or C infection).
•10.Alcohol abuse.

发起方