EFFECTS OF COMBINED ANTIRETROVIRAL THERAPY ON COAGULATION FACTORS

联合抗逆转录病毒治疗对凝血因子的影响

• 批准号: 6283110
• 负责人: M E EYSTER
• 金额: $ 2.16万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6283110
• 关键词: HIV infections; antiAIDS agent; clinical research; coagulation factor IX; coagulation factor VIII; combination chemotherapy; hemophilia As; hemophilia B; human subject; human therapy evaluation; longitudinal human study; pharmacokinetics; platelet activation; platelet aggregation; protease inhibitor

Effects of Combination Antiretroviral Therapy including Indinavir Sulfate on Coagulation Factors, on Platelet Aggregation and on Factor VIII/IX in HIV-1 Seropositive patients with Hemophilia A or B. The objectives of this protocol are to assess whether, in the specific population being studied, a combined therapy of indinavir sulfate NRTIs induces changes in prospectively identified elements of the coagulation system. It is recognized apriori, that due to the nonfeasibility of having a group in which indinivar sulfate is not added to combination NRTI therapy, it will be impossible to determine what changes in the coagulation system, if any, would have been observed in the absence of indinivar sulfate. However, to help assess changes in the pharmacokinetic half-life and recovery of infused factor VIII, protease inhibitor-experienced HIV-1 seropositive hemophilia A patients will serve as a laboratory control group. We hypothesize that after 12 weeks of treatment, coadministration of indinavir sulfate and NRTIs to protease inhibitor-naive HIV-1 seropositive hemophilia A patients will decrease the pharmacokinetic half-life of infused factor Viii compared to pre-indinavir sulfate therapy baseline relative to changes observed in the laboratory control group. Secondarily, during a 52 week coadministration of indinavir sulfate and combination NTRI therapy to protease inhibitor-naive HIV-1 seropositive hemophilia patients after 12 weeks of treatment: the pharmacokinetic recovery of infused factor VIII in hemophilia A patients will be reduced, relative to changes observed in the laboratory control group; the pharmacokinetic half-life of infused factor IX in hemophilia B patients will be reduced and the pharmacokinetic recovery of infused factor IX in hemophilia B patients will be reduced.

包括依地那韦在内的联合抗逆转录病毒治疗的疗效观察 硫酸盐对凝血因子、血小板聚集和因子的影响 HIV-1阳性血友病A、B患者中/IX的检测 该议定书的目标是评估在具体情况下是否 正在研究的人群，硫酸吲地那韦NRTIs的联合治疗 诱导前瞻性确定的凝血成分的变化 系统。它被认为是先验的，由于不可行的 具有不加吲哚硫酸的基团的组合物 NRTI治疗，将不可能确定在 凝血系统，如果有的话，应该已经观察到没有 吲哚瓦硫酸盐。然而，为了帮助评估 输注型凝血因子VIII的药代动力学半衰期和回收率 经验丰富的HIV-1血清阳性血友病A患者将 作为实验室对照组。我们假设12周后 治疗中，联合应用硫酸吲地那韦和硝酸甘油 蛋白酶抑制素HIV-1血清阳性血友病A患者将 降低输注因子VIII的药代动力学半衰期的比较 与观察到的变化相关的硫酸吲地那韦治疗前基线 在实验室对照组。其次，在52周内 联合应用硫酸吲地那韦联合硝普钠治疗 蛋白水解酶抑制剂-单纯HIV-1血清阳性血友病患者治疗后 治疗12周：输注因子的药代动力学恢复 血友病A患者中的VIII会减少，相对变化 在实验室对照组中观察；药代动力学半衰期 血友病B患者输注因子IX的数量将会减少， 血友病B患者输注因子IX的药代动力学恢复 将会减少。