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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
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.
研究者
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