EUCTR2006-000748-14-ES进行中（未招募）不适用
Estudio fase III, aleatorizado, abierto de Lopinavir/ritonavir comprimidos 800/200 mg una vez al día versus 400/100 mg dos veces al día, cuando se coadministran con inhibidores de la transcriptasa inversa análogos de nucleósidos/nucleótidos, en sujetos infectados por el VIH-1 con tratamiento antirretroviral previo. A Phase 3, Randomized, Open-label Study of Lopinavir/ritonavir Tablets 800/200 mg Once-daily Versus 400/100 mg Twice-daily when Coadministered ....
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject will be eligible for study participation if he/she meets the following criteria:
- •1.Subject is at least 18 years of age.
- •2.Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
- •3.Subject agrees not to take any medication during the study, including over the counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs without the knowledge of the principal investigator.
- •4.Subject does not require and agrees not to take any drugs that are contraindicated with study drugs during the course of the study. For complete information, refer to the most current product label for locally approved prescribing information for lopinavir/ritonavir (Kaletra®) and other investigator-selected coadministered antiretroviral agents.
- •5.Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of initiating study drug (as denoted by * in Appendix D). Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with the Abbott Medical Monitor.
- •6.Subject's vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
- •7.If female, subject must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oorphorectomy or hysterectomy), or she must:
- •·use a non-hormonal method of birth control that is acceptable to both the subject and investigator, and is consistent with the locally approved prescribing information for lopinavir/ritonavir; and
- •·have a urine pregnancy test performed at the Screening Visit and on Day 1/Baseline, and results of both tests must be negative.
- •8.Subject is not breast-feeding.
- •9.Subject is currently receiving an antiretroviral regimen which has not changed for at least 12 weeks.
- •10.Subject has never received lopinavir/ritonavir.
- •11.Subject is currently failing his/her antiretroviral regimen with the most recent two consecutive pre-study plasma HIV-1 RNA levels > 400 copies/mL with the most recent being > 1000 copies/mL, and in the investigator's opinion, should change therapy.
- •12.Subject has plasma HIV-1 RNA levels > 1000 copies/mL at Screening.
- •13.Based on HIV-1 drug resistance genotypic test results at the Screening Visit and prior treatment history, the investigator considers lopinavir/ritonavir plus at least two NRTIs to be an appropriate treatment for the subject.
- •14.Subject does not require and agrees not to take any antiretroviral medication except lopinavir/ritonavir and NRTIs.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will be excluded from the study if he/she meets any of the following criteria:
- •1.Subject has a history of an allergic reaction or significant sensitivity to lopinavir or ritonavir.
- •2.Subject has an ongoing history of substance abuse (recreational drugs, alcohol) or psychiatric illness that could preclude adherence with the protocol.
- •3.Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, metabolic or hepatic disease that would adversely affect his/her participating in this study.
- •4.Subject has received any investigational drug or investigational vaccine within 30 days prior to study drug administration.
- •5.For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.
- •6.Screening laboratory analyses show any of the following abnormal laboratory results:
- •?Hemoglobin less than or equal to 8.0 g/dL
- •?Absolute neutrophil count less than or equal to 750 cells/microliter
- •?Platelet count less than or equal to 50,000 mm3
- •?ALT (SGOT) or AST (SGPT) greater than or equal to 5.0 x Upper Limit of Normal (ULN)
研究者
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