A prospective randomized, open-labelled, multi-centre trial comparing the safety and efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to that of Prezista (Darunavir, DRV/r) in three-class (NRTI, NNRTI, and PI) treatment-experienced patients with resistance to more than one PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients - POTENT

BOEHRINGER ING.0 个研究点目标入组 1,040 人开始时间: 2007年7月30日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 1,040

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

•-Signed informed consent prior to trial participation. -HIV-1 infected male or female >= 18 years of age. -Three-class (NRTI, NNRTI, and PI) treatment-experienced patients (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing. -Patient?s optimized background regimen must contain one of the following ARV options: A minimum of two genotypically active nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) reported as ?maximal response? or ?sensitive? on the screening virtual phenotype report. A minimum of one genotypically active NRTI reported as ?maximal response? or ?sensitive? on the screening virtual phenotype report plus Enfuvirtide if not used previously. For patients who had previously taken 3TC (lamivudine) or FTC (emtricitabine), these drugs are not considered as sensitive regardless of the virtual phenotype report. -Patient has been on their current (failing) PI-containing regimen for at least 8 weeks prior to randomization. -An HIV-1 viral load of >=1,000 copies/mL at screening. -A CD4+ cell count of >= 50 cells/mm**3 at screening. -Karnofsky performance score of >= 70. -Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered acceptable if the following apply: ALT <= 2.5 x ULN and AST <= 2.5 x ULN (<= DAIDS Grade 1). Any DAIDS grade cholesterol or triglycerides, GGT, CPK or LDH is acceptable. Urinalysis: hematuria and proteinuria (<= DAIDS Grade 2). Hematology: hemoglobin, absolute neutrophil count, platelets (<= DAIDS Grade 2). Chemistries: glucose, uric acid (<= DAIDS Grade 2). All other laboratory test values (<= DAIDS Grade 1). -Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infections as defined in Appendix 10.3.2. -Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system during the study.
•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

•-Previous use of TPV or DRV. -Full genotypic resistance (reported as ?minimal response?) to TPV or DRV on screening virtual phenotype: ?Minimal response? is defined by the fold change above the Virco upper clinical cutoff values. -Female patient of child-bearing potential who: has a positive serum pregnancy test at screening or during the study, is breast feeding, is planning to become pregnant, is not willing to use barrier methods of contraception or requires ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms. -History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy. -Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit. -Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin-2) within 30 days prior to randomization. -Current use of systemic cytotoxic chemotherapy. -Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator. -All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.

研究者

发起方

BOEHRINGER ING.

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A prospective randomized, open-labelled, multi-centre trial comparing the safety and efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to that of Prezista® (Darunavir, DRV/r) in three-class (NRTI, NNRTI, and PI) treatment-experienced patients with resistance to more than one PI.POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients - POTENT

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