EUCTR2005-005264-86-DE进行中（未招募）不适用
Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (TPV/r) 500 mg/200 mg BID IN a racially and Gender diverse HIV positive treatment experienced population with a pilot evaluation of therapeutic drug monitoring (TDM). The SPRING study is an open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy - SPRING study
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
- 400
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 adults, men and women >=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).
- •3. CD4+ T lymphocyte count =50 cells/mm3.
- •4. HIV-1 viral load >=1,000 copies/mL at screening .
- •5. 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 at least 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 use).
- •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
- •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
- •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 OBR.
- •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. Known hypersensitivity to any of the ingredients to the tipranavir or ritonavir formulations.
- •2. ARV medication naïve.
- •3. Genotypic resistance to TPV (defined as a TPV mutation score >7).
- •4. Prior tipranavir use.
- •5. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
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