PACTG P1026S: PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUG DURING PREGNANCY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 设计：前瞻性药代动力学子研究，受试者入组 PACTG P1025 样本量：每种药物/药物组合的样本量为25例受试者或共125例受试者。 人群：受试者可在妊娠≥ 20周时入组。 受试者必须入组P1025，并且目前在成人剂量下接受以下抗逆转录病毒药物或相互作用复方制剂之一： " 阿巴卡韦（300 mg b.i.d.） " 洛匹那韦/利托那韦（Kaletra）（400/100 mg b.i.d.直至妊娠30周，然后533/133 mg b.i.d.直至获得产后PK评价结果） " 福沙那韦/利托那韦（700/100 mg b.i.d.） " 阿扎那韦/利托那韦（300/100 mg q.d.） " ddI延迟释放（Videx？EC）（400 mg q.d.如果体重> 60 kg; 250 mg q.d.如果体重< 60 kg） " 恩曲他滨（200 mg q.d.） " 替诺福韦（300 mg q.d.） " 替诺福韦/阿扎那韦/利托那韦（300/300/100 mg q.d.） 方案：孕妇将继续服用临床医生开具的抗逆转录病毒药物。 药代动力学评价： 产前：妊娠晚期（30-36周）的外周血标本;采样时间因抗逆转录病毒治疗方案而异。 产时：脐带夹闭时的母体外周血标本和脐带血标本。 产后：产后6-12周采集外周血标本;采样时间因抗逆转录病毒治疗方案而异。 注：如果发现药物水平不足，可进行剂量调整。 新剂量可能高于目前FDA批准的剂量。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. DESIGN: Prospective pharmacokinetic substudy for subjects enrolled in PACTG P1025 SAMPLE SIZE: The sample size will be 25 subjects per drug/drug combination or a total of 125 subjects. POPULATION: Subjects can enroll at = 20 weeks gestation. Subjects must be enrolled in P1025 and currently receiving one of the following antiretroviral drugs or interacting combinations at adult dosing: " abacavir (300 mg b.i.d.) " lopinavir/ritonavir (Kaletra¿) (400/100 mg b.i.d. until 30 weeks gestation, then 533/133 mg b.i.d. until results of postpartum PK evaluation are available) " fosamprenavir/ritonavir (700/100 mg b.i.d.) " atazanavir/ritonavir (300/100 mg q.d.) " ddI delayed release (Videx¿ EC) (400 mg q.d. if weight > 60 kg; 250 mg q.d. if weight < 60 kg) " emtricitabine (200 mg q.d.) " tenofovir (300 mg q.d.) " tenofovir/atazanavir/ritonavir (300/300/100 mg q.d.) REGIMEN: Pregnant women will continue on antiretroviral medications prescribed by their clinicians. Pharmacokinetic evaluations: Antepartum: peripheral blood specimen during third trimester (30-36 weeks); time of sampling will vary by antiretroviral regimen. Intrapartum: maternal peripheral blood specimen at time cord is clamped and cord blood specimen. Postpartum: peripheral blood specimen at 6-12 weeks postpartum; time of sampling will vary by antiretroviral regimen. Note: If it is found that drug levels are not adequate, dose adjustments may be made. The new dose may be higher than the current FDA approved dose.