NL-OMON42090
已完成
2 期
Pharmacokinetics, safety and efficacy of atazanavir /dolutegravir/lamivudine regimen as maintenance regimen in patients with intolerance and/or resistance to NRTIs, NNRTIs and RTV: a pilot study (PRADA II study) - PRADA II
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 9 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- HIV
- 发起方
- niversitair Medisch Centrum Sint Radboud
- 入组人数
- 9
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Trial is onging in other countries
研究者
入排标准
入选标准
- •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.
排除标准
- •1\. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- •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 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 pharmacokinetics: oxcarbamazepine, phenytoin, phenobarbital, carbamazepine, St. John\*s wort, rifampicin, clarithromycin, H2 receptor antagonists, proton pump inhibitors, irinotecan, midazolam, triazolam, buprenorfine, aprepitant, modafinil, imatinib, co\-trimoxazole, other antiretroviral drugs.
- •8\. Concomitant use of medications that are contraindicated for use with atazanavir, dolutegravir or lamivudine: alfuzosin, pimozide, 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.
结局指标
主要结局
未指定
相似试验
已完成
不适用
The ATACAS Trial: Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial. A prospective, randomised, double blind, factorial trial testing whether aspirin, tranexamic acid, or both, can reduce mortality and/or major morbidity after elective coronary artery surgery.CABGheart bypass surgery1001108210007593NL-OMON40015Alfred Hospital29
已完成
不适用
Phase I/II study with the combination of afatinib and selumetinib in advanced KRAS mutant positive and PIK3CA wildtype non-small cell lung cancer and colorectal cancercolorectal cancernon-small cell lung cancer10027476NL-OMON47757Antoni van Leeuwenhoek Ziekenhuis28
已完成
2 期
The efficacy of cabozantinib in advanced salivary gland cancer patients, a phase II clinical trialNL-OMON46770Radboud Universitair Medisch Centrum25
已完成
不适用
An open-label, adaptive multiple-dose study to investigate the pharmacokinetics and pharmacodynamics of RO7234292 in csf and plasma, and safety and tolerability following intrathecal administration in patients with Huntington's disease.Chronic Progressive Choreadegenerative chorea1002929910029317NL-OMON49037Hoffmann-La Roche4
已完成
不适用
Effect of Intravenous Administration of Recombinant Human Activated Protein C on Local Inflammation and Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide in Asthma PatientsAsthma10006436NL-OMON35983Academisch Medisch Centrum28