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 Ingelheim, Canada Ltd.0 个研究点目标入组 800 人开始时间: 2007年7月13日最近更新: 2012年3月19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: 800

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.HIV-1 infected male or female > 18 years of age.
•2.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.
•3.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.
•A minimum of one genotypically active NRTI reported as maximal response” or sensitive” on the screening virtual phenotype report plus an integrase inhibitor if not used previously and if available through an expanded access program and allowed by local regulatory authorities.
•A minimum of one genotypically active NRTI reported as maximal response” or sensitive” on the screening virtual phenotype report plus the CCR5 chemokine receptor antagonist Maraviroc (Pfizer) if available through an expanded access program, not used previously and allowed by local regulatory authorities.
•Zero or one genotypically active NRTI reported as maximal response” or sensitive” on the screening virtual phenotype report plus two of the following drugs, Enfuvirtide, integrase inhibitor and Maraviroc if available, not used previously and allowed by local regulatory authorities.
•For patients who had previously taken 3TC (lamivudine) or FTC (emtricitabine), these drugs are not considered as sensitive regardless of the virtual phenotype report.
•4.Patient has been on their current (failing) PI-containing regimen for at least 8 weeks prior to randomization.
•5.An HIV-1 viral load of =1,000 copies/mL at screening.
•6.A CD4+ cell count of = 50 cells/mm3 at screening.
•7.Karnofsky performance score of = 70 (Appendix 10.7).
•8.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, Appendix 10.1).
•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).
•9.Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infections as defined in Appendix 10.3.2.
•10.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

•1.Previous use of TPV or DRV.
•2.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.
•3.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.
•4.History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
•5.Any AIDS defining illness (Appendix 10.3.1) that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
•6.Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin 2) within 30 days prior to randomization.
•7.Current use of systemic cytotoxic chemotherapy.
•8.Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
•9.All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.

研究者

发起方

Boehringer Ingelheim, Canada Ltd.

相似试验

进行中（未招募）

1 期

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 - POTENTHIV infection

EUCTR2005-001866-15-FRBoehringer Ingelheim France SAS800

进行中（未招募）

不适用

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 - POTENTHIV infectionMedDRA version: 6.1Level: HLTClassification code 10052740

EUCTR2005-001866-15-ITBOEHRINGER ING.1,040

进行中（未招募）

不适用

EUCTR2005-001866-15-DEBoehringer Ingelheim Pharma GmbH & Co. KG800

进行中（未招募）

不适用

EUCTR2005-001866-15-BESCS Boehringer Ingelheim Comm.V800

进行中（未招募）

1 期

EUCTR2005-001866-15-GRBoehringer Ingelheim Ellas AE800