PER-047-14已完成未知
AA5290 Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis Treatment with or without Raltegravir in HIV-1-Infected Persons Requiring Treatment for Active TB and HIV
El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,0 个研究点目标入组 6 人开始时间: 2014年11月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •1.HIV-1 infection,
- •2.CD4+/CD8+ T-cell count obtained within 30 days prior to study entry
- •3.Confirmed or probable pulmonary or extrapulmonary TB
- •4..Chest x-ray within 30 days prior to study entry.
- •5.A PI-based ART regimen is required,
- •6.Laboratory values obtained within 14 days prior to study entry
- •7.For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to study
- •8.All participants must agree not to participate in a conception
- •9.Female participants who are participating in sexual activity that could lead to pregnancy must agree to use at least two reliable methods of contraception
- •10.Karnofsky performance score > 40 within 14 days prior to study entry
- •11.Men and women >18 years of age,
- •12.Ability to swallow oral medications.
- •13.Ability and willingness of participant to provide informed consent.
排除标准
- •1.History of completed TB treatment and resolution of TB symptoms less than 1 year prior to the current TB episode at study entry
- •2.Documented multidrug-resistant tuberculosis (MDR TB) or extensively drug-resistant (XDR) TB.
- •3.Participants infected with a rifamycin resistant strain of TB as determined by HAIN GenoType MTBDR Plus line probe assay or, GeneXpert® MTB/RIF assay
- •4.Receipt of more than 28 cumulative days of anti-TB treatment for the current TB episode prior to study entry.
- •5.Active drug or alcohol use or dependence that, in the opinion of the site investigator
- •6.Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
- •7.Pregnant or breastfeeding.
- •8.Anticipated receipt of any of the prohibited medications
- •9..Known intolerance/allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
- •10.History of close contact with known MDR or XDR TB patients at any time prior to study entry.
研究者
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