RIFAMPIN AND RIFABUTIN EFFECT ON COMBINATION ORAL CONTRACEPTIVES IN HIV PATIENTS

这项研究的所有评估工作已经完成。结果表明， RIF和RBT都显著降低了#年的基准 平均EE2面积下的血药浓度时间曲线(AUC)值。 RIF和RBT后NE的AUC也显著降低 行政部门。EE2的最大血药浓度(Cmax)下降 明显遵循RIF，但不是RBT管理。NE的CMAX 没有明显的变化。与之相比，RIF导致了 两个EE2的AUC的中位数百分比降幅显著更大 NE(p‘s&lt；0.05)和EE2的Cmax(p&lt；0.05)均高于RBT。RIF 导致卵泡的中位数百分比增加38.9[92.7]% 刺激素值表明有减少抑制的趋势 脑下垂体-性腺轴。尽管有这一发现，但对 所有受试者服用RIF或RBT后均发生排卵；血浆 在第21天，所有受试者的孕酮水平均低于1.0 ng/ml。 这项研究的结果将被FDA考虑到 对RBT包装标签的修订。

All evaluations have been completed for the study. Results show that both RIF and RBT resulted in significant reductions from baseline in mean EE2 area under the plasma concentration time curve (AUC) values. AUC's of NE also significantly decreased following RIF and RBT administrations. Maximum plasma concentrations (Cmax) of EE2 decreased significantly following RIF but not RBT administration. Cmax's of NE did not change significantly. When compared, RIF resulted in a significantly greater median percent decrease in the AUC's of both EE2 and NE (p's <0.05) and the Cmax's of EE2 (p < 0.05) than RBT. RIF resulted in a median percent increase of 38.9 [92.7] % in follicle stimulating hormone values suggesting a trend toward less suppression of the pituatary-gonadal axis. In spite of this finding, suppression of ovulation occurred in all subjects after taking RIF or RBT; plasma progesterone levels were less then 1.0 ng/ml in all subjects on day 21. The results of this study will be used by the FDA in consideration of amendments to the package labelling of RBT.