EFFECTS OF COMBINED ANTIRETROVIRAL THERAPY ON COAGULATION FACTORS

包括硫酸茚地那韦在内的联合抗逆转录病毒治疗对HIV-1血清阳性血友病A或B患者凝血因子、血小板聚集和因子VIII/IX的影响 本方案的目的是评估在所研究的特定人群中，硫酸茚地那韦NRTI联合治疗是否会引起凝血系统前瞻性识别要素的变化。 先验地认识到，由于在NRTI联合治疗中不添加硫酸茚地伐的组不可行，因此不可能确定在不存在硫酸茚地伐的情况下观察到的凝血系统的变化（如果有的话）。 然而，为了帮助评估输注因子VIII的药代动力学半衰期和恢复的变化，蛋白酶激活剂经历的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，治疗12周后，与硫酸茚地那韦治疗前基线相比，硫酸茚地那韦和NRTI联合给药蛋白酶促生长剂初治的HIV-1血清阳性血友病A患者输注因子VIII的药代动力学半衰期相对于实验室对照组观察到的变化会缩短。 其次，在12周治疗后，对蛋白酶促生长剂初治的HIV-1血清阳性血友病患者共同给予硫酸茚地那韦和联合NTRI治疗的52周期间：相对于在实验室对照组中观察到的变化，血友病A患者中输注的因子VIII的药代动力学恢复将降低;血友病B患者中输注的因子IX的药代动力学半衰期将缩短，并且血友病B患者中输注的因子IX的药代动力学回收率将降低。

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.