A randomized, open-label trial to compare the efficacy, safety and tolerability of DRV/rtv (800/100 mg) q.d. versus DRV/rtv (600/100 mg) b.i.d. in early treatment-experienced HIV-1 infected subjects. - ND

TIBOTEC PHARMACEUTICALS LTD.0 个研究点目标入组 612 人开始时间: 2007年11月21日最近更新: 2012年9月3日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 612

研究概览入排标准研究者记录与标识符相似试验

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

•1. Male or female subjects, aged 18 years or older. 2. Subjects with documented HIV-1 infection. 3. Stable HAART regimen for at least 12 weeks at screening. 4. In the investigator?s opinion, NNRTIs are not a valid treatment option, because of the subject?s ARV treatment history, ARV resistance testing, medication-taking behavior, safety and tolerability concerns, or other patient-related factors. 5. Prescreening or/and screening plasma HIV-1 RNA > 1,000 copies/mL (assayed by RNA PCR standard specimen procedure) on HAART regimen at screening. 6. Screening genotype resistance test results showing none of the following mutations in the protease gene 11I, 32I, 33F, 47V, 50 V, 54L, 54M, 73S, 76V, 84V and 89V, known as DRV resistance associated mutations [RAMs]. 7. CD4+ cell count > 50 x 106 cells/mL. 8. Subjects have voluntarily signed the ICF. 9. Subjects can comply with the protocol requirements. 10. General medical condition, in the investigator?s opinion, does not interfere with the assessments and the completion of the trial.
•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

•1. Presence of any currently active conditions that fit the definition of the WHO Clinical Stage 4, with the following exceptions: - Stable cutaneous Kaposi?s Sarcoma (i.e., no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial time period, - Wasting syndrome. 2. Current or past alcohol and/or drug use which, in the investigator's opinion, could compromise the subject's safety or adherence to the study protocol procedures. 3. Subjects for whom an investigational ARV is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval): tenofovir, emtricitabine. 4. Previous or current use of ENF, tipranavir and/or DRV. 5. Use of disallowed concomitant therapy (See Section 4.7). 6. Life expectancy of less than 12 months. 7. Pregnant or breast-feeding. 8. Female subject of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period. 9. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation (i.e., liver insufficiency), irrespective of liver enzyme levels. 10. Any active clinically significant disease (e.g., tuberculosis [TB], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator?s opinion, would compromise the subjects safety or outcome of the trial. 11. Subjects with a grade 3 or 4 laboratory abnormality as defined by division of AIDS (DAIDS) grading tables, with the following exceptions unless clinical assessment foresees an immediate health risk to the subject: subjects with pre-existing diabetes with asymptomatic, nonfasting glucose grade 3 or 4 elevations, subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4. 12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication DRV or ritonavir. 13. Use of any non-ARV investigational agents within 60 days prior to screening without prior approval of the sponsor 14.Participation in any other investigational trial without prior approval of the sponsor

研究者

发起方

TIBOTEC PHARMACEUTICALS LTD.

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