RIFAMPIN AND RIFABUTIN EFFECT ON COMBINATION ORAL CONTRACEEPTIVES IN HIV WOMEN

这是一项对照、随机、第一阶段的药物-药物相互作用研究。 目的：评价利福平和利福平对人体药代动力学的影响。 口服避孕药全身联合治疗的药效学研究。 利福平和利福平是用于艾滋病毒感染者的药物 分枝杆菌防治的患者群体 疾病。利福平是一种已知的酶诱导剂，它可以增强 通过肝脏P450代谢的药物的代谢 微粒体酶导致较低的血浆浓度。许多 感染艾滋病毒的异性恋女性选择口服避孕药 避孕。 全身的乙炔雌二醇和 在利福平和利福平存在的情况下，去甲肾上腺素能被降低 这可能会使口服避孕药无效。尽管在那里 一些迹象表明利福布汀可能对 细胞色素P450系统，可能利福布汀有足够的 任何酶的诱导作用，以改变常用的疗效 复方口服避孕药。 这项研究将提供第一次面对面的能力比较 利福平和利福平诱导细胞色素P450功能。在……里面 此外，本研究还将提供一个同步研究的范式 P450诱导剂的药代动力学和药效学效应。 这项研究还可以提供与监管相关的信息 在具体的药品标签中提出剂量建议。这个 结果可能会对这些药物的处方方式产生影响。

This is a controlled, randomized, Phase I, drug-drug, interaction study to evaluate the effect of rifampin and rifabutin on pharmacokinetics and pharmacodynamics of systemic combined oral contraceptive therapy. Rifabutin and rifampin are drugs that are used in the HIV-infected patient population for the prevention and treatment of mycobacterial diseases. Rifampin is a known enzyme inducer which enhances the metabolism of drugs which are metabolized via the hepatic p450 microsomal enzymes resulting in lower plasma concentrations. Many heterosexual HIV-infected women choose to use oral contraceptives for contraception. It is impossible that systemic levels of ethinyl estradiol and norethindrone are lowered in the presence of rifampin and rifabutin which may render the oral contraceptive ineffective. Although there is some suggestion that rifabutin may have less of an effect on the cytochrome p450 system, it is possible that rifabutin may have enough of any enzyme inducing effect to alter the efficacy of the commonly used combination oral contraceptive pill. This study will provide the first head to head comparison of the ability of rifabutin and rifampin to induce cytochrome p450 function. In addition, this study will provide a paradigm to simultaneously study both the pharmacokinetic and pharmacodynamic effects of a P450 inducer. This study may also provide information of regulatory relevance insomuch as making dosing recommendations in the specific drug labels. The results could have impact on how these drugs are prescribed.