EUCTR2005-005023-33-DE进行中（未招募）不适用
Safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500 mg/200 mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV co-infection, with a pilot evaluation of therapeutic drug monitoring (TDM). An open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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 males or females =18 years of age.
- •2. Three-class (NRTI, NNRTI, and PI) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI (on the screening resistance testing). Patients that are NNRTI-naïve patients but who have genotypically documented NNRTI-resistance mutations on past or screening resistance testing would be eligible.
- •3. Chronic hepatitis C Virus infection demonstrated by HCV-RNA positivity or, Chronic hepatitis B infection demonstrated by anti-HBc-IgG Antibody and HB Surface Antigen
- •positivity.
- •4. The ARV study treatment regimen must consist of new TPV/r in combination with an OBR of 2-4 agents of the following: N(t)RTIs (NRTI or NtRTI), enfuvirtide (ENF), and/or, where available, an Expanded Access Program (EAP) investigational agent (Section 3.3). In total, patients are to have an ARV study treatment regimen consisting of at least 3 agents (TPV/r and two OBRs).
- •The following considerations must be applied in construction of the OBR:
- •At least one of the OBR agents must be new (defined as first time patient
- •If two N(t)RTIs are used for the OBR, at least one of the RTIs must be new
- •to the patient with a maximal response” on the Virco resistance analysis
- •report. The other N(t)RTIs in the regimen may have either a maximal or
- •reduced response” on the Virco resistance analysis report.
- •If either new ENF and/or potentially approved new agents (e.g.,
- •raltegravir and maraviroc) are used for the OBR, the N(t)RTIs may have
- •either a maximal or reduced response” on the Virco resistance analysis
- •report. Raltegravir and maraviroc may be accessed commercially if
- •approved or through EAPs where available.
- •N(t)RTIs that are classified as having a minimal or resistant response” on
- •the Virco resistance analysis report may be used but will not count as
- •one of the 2-4 active agents required to be in the OBR.
- •For patients who had previously taken lamivudine (3TC) or emtricitabine
- •(FTC), neither of these drugs is considered as sensitive regardless of the
- •genotype report. If previously taken, either 3TC or FTC may be included in
- •the OBR but will not count as one of the 2-4 agents required to be in the
- •Patients co-infected with HBV already treated at screening with anti-HBV drugs which have also an anti-HIV activity (lamivudine, emtricitabine, tenofovir) should remain on these drugs during the trial. These drugs, however, will not be counted as active anti HIV drugs in the background regimen.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior tipranavir use
- •2. ARV medication naïve.
- •3. Genotypic resistance to TPV (defined as a TPV mutation score >7).
- •4. Decompensated liver disease, including presence or history of ascites, variceal bleeding, or hepatic encephalopathy or having ever been diagnosed as having hepatic insufficiency of Child Pugh class B or C.
- •5. Use of immunomodulatory drugs (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2) or antineoplastic agents within 30 days before study entry or during the trial.
- •6. Anticipated need for any interferon-based regimen in the 48 weeks following the study entry.
研究者
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