RIFAMPIN AND RIFABUTIN EFFECT ON COMBINATION ORAL CONTRACEPTIVES IN HIV PATIENTS

利福平和利福布丁对 HIV 患者联合口服避孕药的影响

• 批准号: 6114314
• 负责人: PATRICIA A BARDITCH-CROVO
• 金额: $ 2.06万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6114314
• 关键词: HIV infections; clinical research; combination chemotherapy; drug interactions; female; human subject; human therapy evaluation; oral contraceptives; rifabutin; rifamycins

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.

研究的所有评价均已完成。结果表明 RIF和RBT均导致较基线的 平均EE 2血浆浓度时间曲线下面积（AUC）值。 RIF和RBT后NE的AUC也显著降低 行政部门。EE 2的最大血浆浓度（Cmax）降低 在RIF给药后显著升高，但在RBT给药后无显著升高。 NE的Cmax 并没有显著改变。相比之下，RIF的结果是 两种EE的AUC的中位百分比降低显著更大2 EE 2的Cmax（p <0.05）高于RBT。RIF 导致卵泡中位百分比增加38.9 [92.7] %， 刺激激素值表明抑制倾向减少 垂体-性腺轴尽管有这一发现， 所有受试者在服用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小于1.0 ng/ml。 FDA将使用本研究的结果， 修订RBT的包装标签。