PACTG P1026S: PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUG DURING PREGNANCY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。设计：PACTG P1025受试者的前瞻性药代动力学亚研究样本量：每种药物/药物组合的样本量为25名受试者，或总共125名受试者。人群：受试者可在妊娠20周时入组。受试者必须参加P1025，目前正在接受以下抗逆转录病毒药物之一或成人剂量的相互作用组合：“阿巴卡韦（300mg b.i.d）。洛匹那韦/利托那韦（Kaletra¿）（每日400/100毫克，直到妊娠30周，然后每日533/133毫克，直到产后PK评估结果可用）阿扎那韦/利托那韦（每日300/100毫克）ddI缓释（Videx¿EC）（如果体重50 ~ 60公斤，每天400毫克；如果体重< 60公斤，每天250毫克）恩曲他滨（每天200毫克）替诺福韦（每日300毫克）替诺福韦/阿扎那韦/利托那韦（每日300/300/100毫克）治疗方案：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）外周血标本；采样时间因抗逆转录病毒治疗方案而异。产时：夹脐带时母体外周血标本及脐带血标本。产后：产后6-12周外周血标本；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，可能会进行剂量调整。新的剂量可能高于目前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.