PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL THERAPY DURING PREGNANCY

点击翻译按钮获取中文摘要

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. This is a substudy of P1025 "Perinatal Core Protocol" study and will enroll a total of 125 women, about 4-5 at this site. The purpose of this study is to find the appropriate dose of selected antiretroviral medications for pregnant women as compared to women who are not pregnant. Women who are taking the following antiretroviral medications: Nevirapine 200 mg 2 times a day, Indinavir/Ritonavir 800/100 mg 2 times a day, Kaletra 400/100 mg 2 times a day, Amprenavir 1200 mg 2 times a day, Abacavir 300 mg 2 times a day, will be included in this study. The patient will be seen two times at the GCRC, once during the last three months of pregnancy and again at 6-12 weeks after delivery, for pharmacokinetics. At each visit, a heparin lock will be placed in the patient's arm and at least five, but no more than eight sample (1-2 teaspoons) of blood will be drawn, depending on the medicines the patient is taking. The total amount of blood that will be drawn at each visit will be about 6-9 teaspoons. At the time of delivery, about two teaspoons of blood will be drawn for routine laboratory tests and to measure the amount of aniretroviral medicine in the patient's blood. A blood sample, about two teaspoons, will also be drawn from the umbilical cord that is attached to the placenta. These samples will be in addition to what will be drawn in P1025. The level of HIV antiretroviral medications will be reported back to the patient and her doctor as soon as possible to help decide, in consultation with the patient's doctors, to increase the amount of medicines. The patient has an option of having the amount of medicine measured in the new dose. The benefit of this substudy is to find the correct amount (dose) of antiretroviral medications in pregnancy which will not be done as a standard of care. The risks are associated with blood drawing and the need to be admitted to GCRC for a day (two times) for the pharmacokinetics. Consent will be obtained in the OB clinic during one of the patient's visits.